Prosthetic valve with radially-deformable tissue anchors configured to restrict axial valve migration

ABSTRACT

A prosthetic valve for implantation within a native heart valve may be provided. The prosthetic valve may include an annular valve body, as well as a plurality of ventricular anchoring legs and a plurality of atrial anchoring arms configured to extend radially outward from the annular valve body. The ventricular anchoring legs and grasping segments of the atrial anchoring arms may be configured to substantially restrict axial movement of the annular valve body within the native heart valve. In addition, anchoring segments of the atrial anchoring arms may be configured for lateral deformation relative to the native heart valve.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority from U.S. Provisional PatentApplication No. 62/560,384, filed Sep. 19, 2017, which is herebyincorporated by reference in its entirety.

TECHNICAL FIELD

This disclosure relates generally to prosthetic valves and deliverysystems for prosthetic valves. More specifically, this disclosurerelates to prosthetic heart valves and methods thereof.

BACKGROUND

The native heart valves (the tricuspid valve, pulmonary valve, mitralvalve, and aortic valve) play an important role in regulating flow ofblood through the cardiovascular system. However, the native heartvalves may become damaged or impaired due to, for example,cardiovascular diseases, infections, or congenital malformations, thuslimiting the ability of the native heart valves to regulate blood flow.This deficiency may result in reduced cardiovascular function or evendeath.

To treat these conditions, prosthetic heart valves may be implanted ator near the site of a damaged or impaired native valve. A prostheticheart valve may assist or replace the functionality of an impairednative valve, leading to better regulation of blood flow and improvedcardiovascular function. However, many existing prosthetic heart valvesrequire implantation via an open heart procedure, which ishighly-invasive and may cause life-threatening complications. Otherprosthetic valves may be collapsed within a prosthetic valve deliverysystem and advanced into the heart, at which point the prosthetic valvemay be removed from the delivery system and expanded at the native valvesite. However, many of these prosthetic valves are large in size andtherefore difficult to deliver into the heart without causing damage tohealthy tissue along the implantation route. In addition, once theseprosthetic valves are situated within the heart, they may be difficultto securely implant at the native valve site due to their complexstructure and the limited maneuverability of existing prosthetic valvedelivery systems within the heart. Moreover, many prosthetic valves areso large that they may protrude several centimeters into surroundingheart chambers once they are implanted, impairing cardiac filling andcausing injury to the anatomy within the heart.

Thus, there remains a need for prosthetic heart valves that are smallerin size but that are still configured to assist or replace thefunctionality of a diseased or damaged native heart valve. In addition,there remains a need for prosthetic heart valves that are more easilymaneuvered into the heart and securely implanted at the site of a nativeheart valve. Moreover, there remains a need for improved prostheticheart valve delivery systems that are configured to securely implant aprosthetic heart valve at an implantation site. The present disclosureprovides prosthetic heart valves with a reduced axial length such thatthe prosthetic heart valves may be more easily delivered into the heartand may exhibit less protrusion into the chambers of the heart. Thepresent disclosure also provides improved prosthetic heart valvedelivery systems and methods of implanting prosthetic heart valves, suchthat prosthetic heart valves may be securely anchored at theimplantation site.

SUMMARY

The present disclosure discloses prosthetic valves for implantationwithin a native mitral valve and methods for implanting prostheticvalves within a native mitral valve. Particular examples of thedisclosure may pertain to a prosthetic valve including tissue anchorsconfigured to restrict axial movement of the prosthetic valve, and alsoconfigured for lateral deformation relative to native valve tissue.

According to an exemplary embodiment of the present disclosure, aprosthetic valve for implantation within a native heart valve isprovided. The prosthetic valve includes an annular valve body. Theprosthetic valve additionally includes a plurality of ventricularanchoring legs configured to extend radially outward from the annularvalve body to respective terminal leg ends. The prosthetic valveadditionally includes a plurality of atrial anchoring arms configured toextend radially outward from the annular valve body. Each atrialanchoring arm includes a grasping segment situated within a radiallyinner portion of the atrial anchoring arm and an anchoring segmentsituated within a radially outer portion of the atrial anchoring arm.The ventricular anchoring legs and the grasping segments of the atrialanchoring arms are configured to substantially restrict axial movementof the annular valve body within the native heart valve. The anchoringsegments of the atrial anchoring arms are configured for lateraldeformation relative to the native heart valve.

The ventricular anchoring legs and the grasping segments of the atrialanchoring arms are configured to grasp heart valve tissue and tosubstantially restrict axial and lateral movement of the annular valvebody relative to the grasped tissue. The ventricular anchoring legs andthe grasping segments of the atrial anchoring arms are configured toapply opposing grasping forces upon the native heart valve. The annularvalve body is configured to be implanted in the native heart valveindependent of the rotational position of the atrial anchoring arms andventricular anchoring legs relative to the native heart valve. Theanchoring segments of the atrial anchoring arms are configured forgreater flexibility than the ventricular anchoring legs and the graspingsegments of the atrial anchoring arms. Flexibility of the anchoringsegments of the atrial anchoring arms is imparted through a structurehaving multiple curves. The ventricular anchoring legs and the graspingsegments of the atrial anchoring arms are devoid of the structure havingmultiple curves. The flexibility of each ventricular anchoring leg issubstantially the same. A portion of at least one atrial anchoring armis configured to be substantially aligned in a common lateral plane witha portion of at least one ventricular anchoring leg. At least themajority of the anchoring segment of the at least one atrial anchoringarm is configured to be situated radially external to the portion of theat least one atrial anchoring arm aligned in the common lateral plane.The grasping segment of at least one atrial anchoring arm is configuredto have a length substantially equal to a length of at least oneventricular anchoring leg. The grasping segment of at least one atrialanchoring arm includes a first portion configured to extend in an atrialdirection, and a second portion configured to extend in a ventriculardirection. The second portion of the grasping segment is configured tobe situated radially external to the first portion of the graspingsegment. The anchoring segment of at least one atrial anchoring armincludes a first portion configured to extend in a ventriculardirection, and a second portion configured to extend in an atrialdirection. The second portion of the anchoring segment is configured tobe situated radially external to the first portion of the anchoringsegment. An entire length of at least one ventricular anchoring leg isconfigured to extend in an atrial direction. The ventricular anchoringlegs are angularly offset from the atrial anchoring arms. Terminal armends of the atrial anchoring arms are configured to be situated radiallyexternal to the terminal leg ends. At least one atrial anchoring arm isconfigured for radial movement independent of the other atrial anchoringarms. At least one ventricular anchoring leg is configured for radialmovement independent of the other ventricular anchoring legs. Theannular valve body includes an atrial end, a ventricular end oppositethe atrial end, and an intermediate portion extending between the atrialend and the ventricular end of the annular valve body. The atrialanchoring arms and the ventricular anchoring legs are configured toextend from the intermediate portion of the annular valve body. Theannular valve body includes an atrial inlet opening at the atrial end ofthe annular valve body. At least one atrial anchoring arm is configuredto have a length larger than the radius of the atrial inlet opening ofthe annular valve body. The annular valve body includes an annular outerframe, the ventricular anchoring legs extending from the outer frame.The annular valve body also includes an inner frame situated at leastpartially within the annular outer frame, the atrial anchoring armsextending from the inner frame. At least one of the outer frame andinner frame are symmetrical.

Additional features and advantages of the disclosed embodiments will beset forth in part in the description that follows, and in part will beobvious from the description, or may be learned by practice of thedisclosed embodiments. The features and advantages of the disclosedembodiments will be realized and attained by the elements andcombinations particularly pointed out in the appended claims.

It is to be understood that both the foregoing general description andthe following detailed description are examples and explanatory only andare not restrictive of the disclosed embodiments as claimed.

The accompanying drawings constitute a part of this specification. Thedrawings illustrate several embodiments of the present disclosure and,together with the description, serve to explain the principles of thedisclosed embodiments as set forth in the accompanying claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a front elevation view of an exemplary frame for aprosthetic valve, consistent with various embodiments of the presentdisclosure.

FIG. 1B illustrates a perspective view of the exemplary frame of FIG.1A, consistent with various embodiments of the present disclosure.

FIG. 2A illustrates a front elevation view of another exemplary framefor a prosthetic valve, consistent with various embodiments of thepresent disclosure.

FIG. 2B illustrates a top plan view of the exemplary frame of FIG. 2A,consistent with various embodiments of the present disclosure.

FIG. 2C illustrates an enlarged view of an atrial anchoring arm and aventricular anchoring leg of the exemplary frame of FIG. 2A, consistentwith various embodiments of the present disclosure.

FIG. 2D illustrates another front elevation view of the exemplary frameof FIG. 2A, consistent with various embodiments of the presentdisclosure.

FIG. 2E illustrates another top plan view of the exemplary frame of FIG.2A, consistent with various embodiments of the present disclosure.

FIG. 3A illustrates a front elevation view of an inner frame of theexemplary frame of FIG. 2A, consistent with various embodiments of thepresent disclosure.

FIG. 3B illustrates an enlarged view of an atrial anchoring arm of theexemplary inner frame of FIG. 3A, consistent with various embodiments ofthe present disclosure.

FIG. 3C illustrates a front elevation view of an outer frame of theexemplary frame of FIG. 2A, consistent with various embodiments of thepresent disclosure.

FIG. 3D illustrates an enlarged view of a ventricular anchoring leg ofthe exemplary outer frame of FIG. 3C, consistent with variousembodiments of the present disclosure.

FIG. 4A illustrates a cross-sectional view of the exemplary frame ofFIG. 2A, consistent with various embodiments of the present disclosure.

FIG. 4B illustrates an enlarged view of a volume between an atrialanchoring arm and a ventricular anchoring leg of the exemplary frame ofFIG. 4A, consistent with various embodiments of the present disclosure.

FIGS. 5A-5E illustrate structural changes in the exemplary frame of FIG.2A during transitioning of the frame between a radially-contractedconfiguration and a radially-expanded configuration, consistent withvarious embodiments of the present disclosure.

FIG. 6A illustrates a front elevation view of an exemplary prostheticvalve, consistent with various embodiments of the present disclosure.

FIG. 6B illustrates a cross-sectional view of the exemplary prostheticvalve of FIG. 6A without leaflets, consistent with various embodimentsof the present disclosure.

FIG. 6C illustrates a cross-sectional view of the exemplary prostheticvalve of FIG. 6A with leaflets, consistent with various embodiments ofthe present disclosure.

FIG. 6D illustrates a top plan view of the exemplary prosthetic valve ofFIG. 6A with uninflated leaflets, consistent with various embodiments ofthe present disclosure.

FIG. 6E illustrates a top plan view of the exemplary prosthetic valve ofFIG. 6A with inflated leaflets, consistent with various embodiments ofthe present disclosure.

FIG. 7A illustrates an exemplary prosthetic valve delivery system,consistent with various embodiments of the present disclosure.

FIG. 7B illustrates an enlarged view of a delivery capsule of theexemplary prosthetic valve delivery system of FIG. 7A, consistent withvarious embodiments of the present disclosure.

FIG. 7C illustrates an exemplary configuration of a telescoping catheterassembly and the delivery capsule of the exemplary prosthetic valvedelivery system of FIG. 7A, consistent with various embodiments of thepresent disclosure.

FIG. 7D illustrates another exemplary configuration of the telescopingcatheter assembly and delivery capsule of FIG. 7C, consistent withvarious embodiments of the present disclosure.

FIG. 8A illustrates another enlarged view of the exemplary deliverycapsule of the prosthetic valve delivery system of FIG. 7A in a closedconfiguration, consistent with various embodiments of the presentdisclosure.

FIG. 8B illustrates the exemplary delivery capsule of FIG. 8A in an openconfiguration, consistent with various embodiments of the presentdisclosure.

FIG. 8C illustrates an interior view of the exemplary delivery capsuleof FIG. 8A in the closed configuration, consistent with variousembodiments of the present disclosure.

FIG. 9 illustrates advancement of the exemplary prosthetic valvedelivery system of FIG. 7A into the left atrium, consistent with variousembodiments of the present disclosure.

FIGS. 10A-10H depict implantation of the prosthetic valve of FIGS. 6A-6Ewithin a native mitral valve by the exemplary prosthetic valve deliverysystem of FIG. 7A, consistent with various embodiments of the presentdisclosure.

DETAILED DESCRIPTION

Exemplary embodiments are described with reference to the accompanyingdrawings. In the figures, which are not necessarily drawn to scale, theleft-most digit(s) of a reference number identifies the figure in whichthe reference number first appears. Wherever convenient, the samereference numbers are used throughout the drawings to refer to the sameor like parts. While examples and features of disclosed principles aredescribed herein, modifications, adaptations, and other implementationsare possible without departing from the spirit and scope of thedisclosed embodiments. Also, the words “comprising,” “having,”“containing,” and “including,” and other similar forms are intended tobe equivalent in meaning and be open ended in that an item or itemsfollowing any one of these words is not meant to be an exhaustivelisting of such item or items, or meant to be limited to only the listeditem or items. It should also be noted that as used in the presentdisclosure and in the appended claims, the singular forms “a,” “an,” and“the” include plural references unless the context clearly dictatesotherwise.

In some embodiments of the present disclosure, an “atrial direction” mayrefer to a direction extending towards an atrium of the heart. Forexample, from a location within the left ventricle or the mitral valve,an atrial direction may refer to a direction extending towards the leftatrium. Additionally, from a location within an atrium (e.g., the leftatrium), an atrial direction may refer to a direction extending awayfrom an adjacent atrioventricular valve (e.g., the mitral valve) andfurther into the atrium. For example, in FIGS. 10G and 10H, an atrialdirection may refer to a direction extending upwards from prostheticvalve 6000 towards atrium 9010. In some exemplary embodiments, an atrialdirection need not necessarily be parallel to a longitudinal axis of aprosthetic valve (e.g., longitudinal axis 2800 illustrated in FIG. 2A),so long as the direction is angled towards an atrium. The atrialdirection may be parallel to a longitudinal axis of a prosthetic valvein some cases. In some embodiments, a “non-ventricular direction” mayrefer to a direction that does not extend towards a ventricle of theheart. A “non-ventricular direction” may extend in an atrial direction,or it may extend laterally in a direction perpendicular to a ventriculardirection.

In some exemplary embodiments of the present disclosure, a “ventriculardirection” may refer to a direction extending towards a ventricle of theheart. From a location within the left atrium or the mitral valve, aventricular direction may refer to a direction extending towards theleft ventricle. Additionally, from a location within a ventricle (e.g.,the left ventricle), a ventricular direction may refer to a directionextending away from an adjacent atrioventricular valve (e.g., the mitralvalve) and further into the ventricle. For example, in FIGS. 10G and10H, a ventricular direction may refer to a direction extendingdownwards from prosthetic valve 6000 towards ventricle 9020. In someexemplary embodiments, a ventricular direction need not necessarily beparallel to a longitudinal axis of a prosthetic valve (e.g.,longitudinal axis 2800 illustrated in FIG. 2A), so long as the directionis angled towards a ventricle. The ventricular direction may be parallelto a longitudinal axis of a prosthetic valve in some cases. In someembodiments, a “non-atrial direction” may refer to a direction that doesnot extend towards an atrium of the heart. A non-atrial direction mayextend in a ventricular direction, or it may extend laterally in adirection perpendicular to an atrial direction.

Exemplary embodiments generally relate to prosthetic valves forimplantation within a native valve and methods for implanting prostheticvalves within a native valve. In addition, exemplary embodimentsgenerally relate to systems and methods for implantation of prostheticvalves by prosthetic valve delivery systems. While the presentdisclosure provides examples relating to prosthetic heart valves, and inparticular prosthetic mitral valves, as well as delivery systems forprosthetic heart valves, it should be noted that aspects of thedisclosure in their broadest sense are not limited to a prosthetic heartvalve. Rather, the foregoing principles may be applied to otherprosthetic valves as well. In various embodiments in accordance with thepresent disclosure, the term prosthetic valve refers generally to animplantable valve configured to restore and/or replace the functionalityof a native valve, such as a diseased or otherwise impaired native heartvalve.

An exemplary prosthetic valve may include a prosthetic valve configuredto render a native valve structure non-functional, and may thus replacethe function of the native valve. For example, an exemplary prostheticvalve may have a size and shape similar to the valve being replaced andmay include a number of leaflet-like structures to regulate fluid flowand prevent backflow of blood through the valve. Additionally, oralternatively, an exemplary prosthetic valve may also include aprosthetic valve configured to leave the native valve structure intactand functional. An exemplary prosthetic valve may include a mitralvalve, tricuspid valve, aortic valve, or pulmonary valve, as well as avalve outside of the heart, such as a venous valve, lymph node valve,ileocecal valve, or any other structure configured to control and/orregulate fluid flow in the body. An exemplary prosthetic valve mayadditionally or alternatively be configured to replace a failedbioprosthesis, such as a failed heart valve prosthesis.

FIG. 1A illustrates a front elevation view of an exemplary frame 1000for a prosthetic valve. FIG. 1B illustrates a perspective view of frame1000. Frame 1000 may be constructed of a shape memory material such asnickel titanium alloy (Nitinol) and may be configured to support othercomponents of the prosthetic valve, such as prosthetic leaflets andprotective cover layers. Frame 1000 may include an annular outer frame1200 and an inner frame 1400 situated at least partially within theouter frame 1200. Annular outer frame 1200 and inner frame 1400 may besecured together by pins, screws, welding, soldering, adhesive, magnets,and/or any other suitable mechanism. For example, FIGS. 1A and 1 Bdepict annular outer frame 1200 and inner frame 1400 connected by aplurality of connector pins 1040.

Annular outer frame 1200 may include an outer frame tubular portion1220, which may be formed of a plurality of struts intersecting atjunctions to form a wire mesh, stent-like, or cage-like structure of theouter frame tubular portion 1220. Annular outer frame 1200 may alsoinclude at least one ventricular anchoring leg 1240, which may beconfigured to extend radially outward from the outer frame tubularportion and which may contact, or otherwise engage, tissue within ornear the native valve to anchor the prosthetic valve within the nativevalve. In some embodiments, exemplary valve frame 1000 may includetwelve ventricular anchoring legs 1240, which may be configured toengage ventricular tissue of a native atrioventricular valve.

Inner frame 1400 may include an inner frame tubular portion 1420, whichmay be formed of a plurality of struts intersecting at junctions to forma wire mesh, stent-like, or cage-like structure of the inner frametubular portion 1420. Inner frame 1400 may also include at least oneatrial anchoring arm 1440, which may be configured to extend radiallyoutward from the inner frame tubular portion and which may contact, orotherwise engage, tissue within or near the native valve to anchor theprosthetic valve within the native valve. In some embodiments, exemplaryvalve frame 1000 may include twelve atrial anchoring arms 1440, whichmay be configured to engage atrial tissue of a native atrioventricularvalve.

Outer frame tubular portion 1220 and inner frame tubular portion 1420may together form an annular valve body 1020 of the prosthetic valve,which may have at least one opening and from which the ventricularanchoring legs 1240 and atrial anchoring arms 1440 may extend. Annularvalve body 1020 may include an axial lumen 1022 extending through theannular valve body 1020 along a longitudinal axis 1800 of the prostheticvalve. In some embodiments, annular valve body 1020 may be configured toreceive a flow control device, such as one or more prosthetic leaflets,within axial lumen 1022. Optionally, annular valve body 1020 may includeone or more atrial end delivery posts 1027 along an atrial end (i.e.,top end) of the annular valve body and/or one or more ventricular enddelivery posts 1028 along a ventricular end (i.e., bottom end) of theannular valve body. Delivery posts 1027 and 1028 may be configured toremovably engage a delivery device of the prosthetic valve, for example,to assist with placement of frame 1000 within or near a native valve.

FIG. 2A illustrates a front view of another exemplary frame 2000 for aprosthetic valve. FIG. 2B illustrates a top plan view of the frame 2000.Frame 2000 may include an annular outer frame 2200 and an inner frame2400 situated at least partially within the annular outer frame 2200.Annular outer frame 2200 and inner frame 2400 may be secured together bypins, screws, welding, soldering, adhesive, magnets, and/or any othersuitable mechanism. For example, FIGS. 2A and 2B depict annular outerframe 2200 and inner frame 2400 connected by a plurality of connectorpins 2040.

Annular outer frame 2200 may include an outer frame tubular portion3605, which may be formed of a plurality of struts intersecting atjunctions to form a wire mesh, stent-like, or cage-like structure of theouter frame tubular portion 3605. For example, as illustrated in FIG.2A, annular outer frame 2200 may include outer frame atrialcircumferential struts 3608 a, outer frame leg base struts 3608 b, andouter frame ventricular circumferential struts 3608 c intersecting atatrial end outer frame junctions 3602, leg attachment junctions 3802,outer frame junctions 3804, and ventricular end outer frame junctions3604 to form outer frame tubular portion 3605. Annular outer frame 2200may also include at least one ventricular anchoring leg 2240, which mayextend from leg attachment junction 3802 of the outer frame tubularportion 3605 and which may be configured to engage ventricular tissue ofa native valve to anchor the prosthetic valve in the native valve. Theat least one ventricular anchoring leg 2240 may include a proximal legend 3622, which may be the end of the leg connected to the outer frametubular portion, and a distal leg end 2244, which may be situatedradially outward from the outer frame tubular portion. As shown in FIG.2B, the at least one ventricular anchoring leg 2240 may include at leastone opening 2242.

Inner frame 2400 may include an inner frame tubular portion 3005, whichmay be formed of a plurality of struts intersecting at junctions to forma wire mesh, stent-like, or cage-like structure of the inner frametubular portion 3005. For example, as illustrated in FIG. 2A, innerframe 2400 may include inner frame atrial struts 3008 a, inner frameintermediate struts 3008 b, and inner frame ventricular struts 3008 cintersecting at atrial end inner frame junctions 3002, arm attachmentjunctions 3202, inner frame strut junctions 3204, and ventricular endinner frame junctions 3004 to form inner frame tubular portion 3005.Inner frame 2400 may also include at least one atrial anchoring arm2440, which may extend from arm attachment junction 3202 of the innerframe tubular portion 3005 and which may be configured to engage atrialtissue of a native valve to anchor the prosthetic valve in the nativevalve. The at least one atrial anchoring arm 2440 may include a proximalarm end 3020, which may be the end of the arm connected to the innerframe tubular portion, and a distal arm end 2444, which may be situatedradially outward from the inner frame tubular portion. As shown in FIG.2B, the at least one atrial anchoring arm 2440 may include a proximalarm opening 2441 and a distal arm opening 2442.

Outer frame tubular portion 3605 and inner frame tubular portion 3005may together form an annular valve body 2020 of the prosthetic valve,which may have at least one opening and from which the ventricularanchoring legs 2240 and atrial anchoring arms 2440 may extend. Annularvalve body 2020 may include an axial lumen 2022 extending through theannular valve body 2020 along a longitudinal axis 2800 of the prostheticvalve. Annular valve body 2020 may have an atrial end 2024, aventricular end 2025 opposite the atrial end, and an intermediateportion 2026 extending between the atrial and ventricular ends. In someembodiments, the atrial end may refer to the portion of the annularvalve body configured to be situated at a location within the atriumthat is furthest from an adjacent ventricle, when the prosthetic valveis implanted in a native valve. Similarly, the ventricular end may referto the portion of the annular valve body configured to be situated at alocation within the ventricle that is furthest from an adjacent atrim,when the prosthetic valve is implanted in a native valve. Theintermediate portion 2026 may extend between the atrial end 2024 andventricular end 2025. In some embodiments, annular valve body 2020 mayinclude one or more ventricular end delivery posts 1028 along theventricular end 2025 of the annular valve body. Axial lumen 2022 mayinclude an inlet opening 2032 at the atrial end of the annular valvebody, as well as an outlet opening 2036 at the ventricular end of theannular valve body.

FIG. 2C illustrates an enlarged view of an atrial anchoring arm 2440 anda ventricular anchoring leg 2240 of frame 2000. Ventricular anchoringleg 2240 may include an inner, atrially-facing leg surface 2248 and anouter, ventricularly-facing leg surface 2249. Atrial anchoring arm 2440may include an atrially-facing arm surface 2448 and aventricularly-facing arm surface 2449. In some embodiments, atrialanchoring arm 2440 may include an arm portion 2446 configured to bearranged in a common lateral plane with leg portion 2246 of theventricular anchoring leg 2240. That is, leg portion 2246 and armportion 2446 may be positioned at the same axial position alonglongitudinal axis 2800.

FIG. 2D illustrates another front elevation view of frame 2000. Theexemplary prosthetic valve, as well as frame 2000, may have an axialheight 2560, which may extend between terminal arm ends 2444 andventricular end 2025 of the annular valve body. Inner frame tubularportion 3005 may have an axial height 2530, which may extend betweenatrial end inner frame junctions 3002 and ventricular end inner framejunctions 3004. Annular outer frame 2200 may have an axial height 2550,which may extend between terminal leg ends 2244 and ventricular end 2025of the annular valve body. Outer frame tubular portion 3605 may have anaxial height 2570, which may extend between atrial end outer framejunctions 3602 and ventricular end outer frame junctions 3604. In someembodiments, frame 2000 may have a ventricular device protrusiondistance 2540, which may represent the distance over which theprosthetic valve protrudes into a left ventricle when the prostheticvalve is implanted in a native mitral valve. Annular valve body 2020 mayinclude a valve inlet radius 2520, which may be the radius of atrialinlet opening 2032.

FIG. 2E illustrates another top plan view of frame 2000. The atrialanchoring arms 2440 may have a length 2580, and the ventricularanchoring legs 2240 may have a length 2590. The terminal arm ends 2444may define an atrial anchoring arm circumference 2640. The terminal legends 2244 may define a ventricular anchoring leg circumference 2620,which may be concentric with atrial anchoring arm circumference 2640.Inflexible portions 3402 of the atrial anchoring arms (illustrated inFIG. 3B) may have a length 2581. Serpentine structures 3406 of theatrial anchoring arms (illustrated in FIG. 3B) may have a length 2582.

FIG. 3A illustrates a front elevation view of inner frame 2400. Theatrial end inner frame junctions 3002 and ventricular end inner framejunctions 3004 may form the atrial end and ventricular end,respectively, of inner frame 2400. Inner frame intermediate portion 3006may extend between atrial end inner frame junctions 3002 and ventricularend inner frame junctions 3004. Inner frame tubular portion 3005 mayhave a radially inner surface 3018 and a radially outer surface 3016.Inner frame atrial struts 3008 a and inner frame intermediate struts3008 b may intersect at atrial end inner frame junctions 3002, armattachment junctions 3202, and strut junctions 3204 to form a first,atrial row of closed cells 3012. Inner frame intermediate struts 3008 band inner frame ventricular struts 3008 c may intersect at armattachment junctions 3202, strut junctions 3204, and ventricular endinner frame junctions 3004 to form a second, ventricular row of closedcells 3014. At least one inner frame atrial strut 3008 a may have across-sectional area 3010. At least one atrial anchoring arm 2440 mayhave a cross-sectional area 3022.

FIG. 3B illustrates an enlarged view of an atrial anchoring arm 2440 ofinner frame 2400. Atrial anchoring arm 2440 may include a proximal armportion 3502 configured to extend in an atrial direction, intermediatearm portion 3504 configured to extend in a ventricular direction, anddistal arm portion 3506 configured to extend in an atrial direction. Armtransition portion 3508 may represent the transition betweenintermediate arm portion 3504 and distal arm portion 3506. Atrialanchoring arm 2440 may also include an inflexible portion 3402 extendingto proximal arm end 3020, as well as a serpentine structure 3406, whichmay be situated radially external to the inflexible portion 3402.Inflexible portion 3402 may have a proximal end 3402p, a distal end 3402d, and a cross-sectional area 3402 c. Serpentine structure 3406 may havea cross-sectional area 3406 c. In some embodiments, atrial anchoring arm2440 may include a terminal arm region 3408 situated radially externalto serpentine structure 3406. Distal arm opening 2442 may be situatedwithin terminal arm region 3408.

FIG. 3C illustrates a front elevation view of outer frame 2200. Theatrial end outer frame junctions 3602 and ventricular end outer framejunctions 3604 may form the atrial end and ventricular end,respectively, of annular outer frame 2200. Outer frame intermediateportion 3606 may extend between atrial end outer frame junctions 3602and ventricular end outer frame junctions 3604. Outer frame tubularportion 3605 may have a radially outer surface 3618 and a radially innersurface 3620. The outer frame atrial circumferential struts 3608 a,outer frame leg base struts 3608 b, and outer frame ventricularcircumferential struts 3608 c may intersect at the atrial end outerframe junctions 3602, leg attachment junctions 3802, outer framejunctions 3804, and ventricular end outer frame junctions 3604 to formclosed cells 3616. At least one outer frame atrial circumferential strut3608 a may have a cross-sectional area 3610 and a width 3612. At leastone outer frame leg base strut 3608 b may have a cross-sectional area3614. At least one ventricular anchoring leg may have a cross-sectionalarea 3624 and a radially outer surface width 3626.

FIG. 3D illustrates an enlarged view of a portion of a ventricularanchoring leg 2240 of annular outer frame 2200. Ventricular anchoringleg 2240 may include a first, proximal curved portion 3807 and a second,distal curved portion 3808. In some embodiments, proximal curved portion3807 may face radially outward. Additionally, or alternatively, distalcurved portion 3808 may face radially inwards.

FIG. 4A illustrates a cross-sectional view of frame 2000, and FIG. 4Billustrates an enlarged view of a portion of FIG. 4A depicting a volume4000 formed between the atrial anchoring arms 2440 and ventricularanchoring legs 2240. FIG. 4B also depicts an outer surface 4010 andinner surface 4020 of annular valve body 2020. In some embodiments,volume 4000 may be bounded by the ventricularly-facing surfaces 2449 ofatrial anchoring arms 2440, by the inner, atrially-facing surfaces 2248of ventricular anchoring legs 2240, and by the outer surface 4010 of theannular valve body 2020.

FIG. 5A illustrates a configuration of the exemplary prosthetic valve inwhich annular valve body 2020, atrial anchoring arms 2440, andventricular anchoring legs 2240 are arranged in a radially-contractedconfiguration. In some embodiments, the configuration illustrated inFIG. 5A may constitute a radially-contracted configuration of theprosthetic valve.

FIG. 5B illustrates a configuration of the exemplary prosthetic valve inwhich annular valve body 2020 and atrial anchoring arms 2440 arearranged in a radially-contracted configuration. In the configuration ofFIG. 5B, the ventricular anchoring legs 2240 may deflect radiallyoutward away from annular valve body 2020, into a radially-expandedconfiguration of the ventricular anchoring legs 2240.

FIG. 5C illustrates a configuration of the exemplary prosthetic valve inwhich annular valve body 2020 and ventricular anchoring legs 2240 arearranged in a radially-contracted configuration. In the configuration ofFIG. 5C, the atrial anchoring arms 2440 may deflect radially outwardaway from annular valve body 2020, into a radially-expandedconfiguration of the atrial anchoring arms 2440.

FIG. 5D illustrates a configuration of the exemplary prosthetic valve inwhich the atrial anchoring arms 2440 and ventricular anchoring legs 2240may deflect radially outward away from annular valve body 2020 intotheir respective radially-expanded configurations, while annular valvebody 2020 remains in a radially-contracted configuration. In theconfiguration of FIG. 5D, an axial distance 5004 may be formed betweenthe atrial anchoring arms 2440 and the terminal ends 2244 of theventricular anchoring legs 2240.

FIG. 5E illustrates a configuration of the exemplary prosthetic valve inwhich annular valve body 2020, atrial anchoring arms 2440, andventricular anchoring legs 2240 are arranged in a radially-expandedconfiguration. In some embodiments, the configuration illustrated inFIG. 5E may constitute a radially-expanded configuration of theprosthetic valve.

FIG. 6A illustrates a front elevation view of prosthetic valve 6000. Insome embodiments, prosthetic valve 6000 may be assembled upon frame2000. Prosthetic valve 6000 may be configured for implantation within ornear a native valve structure and may be configured to restore and/orreplace the functionality of a native valve, such as a diseased orotherwise impaired native valve. Prosthetic valve 6000 may include valveframe 2000, including annular valve body 2020, the atrial anchoring arms2440, and the ventricular anchoring legs 2240. Prosthetic valve 6000 mayalso include a skirt layer 6100 configured around an external surface ofa portion of the annular valve body. Prosthetic valve 6000 mayadditionally include a first cuff sheet 6210, which may be connected toskirt layer 6100 via stitching 6104, as well as a second cuff sheet6220, which may be connected to first cuff sheet 6210 via stitching6420. In some embodiments, the first cuff sheet 6210 and second cuffsheet 6220 by extend around the terminal ends 2444 of the atrialanchoring arms 2440. Skirt layer 6100, first cuff sheet 6210, and secondcuff sheet 6220 may be constructed of fluid-impermeable material and mayaccordingly be configured to prevent passage of blood or other fluidsthrough portions of the prosthetic valve 6000 outside of the axial lumen2022.

In some embodiments, prosthetic valve 6000 may additionally include aprotective sleeve 6102 wrapped around the rim 6800 of the ventricularoutlet opening of annular valve body 2020; protective sleeve 6102 may besecured to annular valve body 2020 by stitching 6108. Additionally, oralternatively, prosthetic valve 6000 may include at least one liner 6310extending around an external surface of the ventricular anchoring legs2240, with at least one protective layer 6330 positioned around thedistal leg ends 2244 and at least one protective covering 6320 wrappedaround the proximal leg ends 3622. In some embodiments, the at least oneprotective covering 6320 may be secured to the skirt layer 6100 viastitching 6322.

FIG. 6B illustrates a cross-sectional view of prosthetic valve 6000,without prosthetic leaflets situated within the axial lumen 2022. Asillustrated in FIG. 6B, prosthetic valve 6000 may additionally include aliner 6400 covering at least a portion of the inner surface 4020 of theannular valve body 2020. Liner 6400 may be secured to the annular valvebody 2020 via stitching 6430 and to the second cuff sheet 6220 viastitching 6410. First cuff sheet 6210, second cuff sheet 6220, and innerliner 6400 may together form an inflatable cuff 6200 having an interiorvolume 6500. In some embodiments, inflatable cuff 6200 may be secured toatrial anchoring arm 2440 via connector 6440. Blood may enter the cuff6200 through openings 6230, causing the cuff 6200 to inflate radiallyoutwards and axially in an atrial direction. In some embodiments, cuff6200 may inflate radially outwards and press against tissue of thenative valve. This engagement between the cuff and tissue of the nativevalve may form a barrier to flow of blood and other fluids around theouter circumference of the prosthetic valve 6000.

FIG. 6C illustrates a cross-sectional view of prosthetic valve 6000 withprosthetic leaflets 6602 and 6604 situated within the axial lumen 2022.In some embodiments, prosthetic valve 6000 may also include a thirdprosthetic leaflet 6606, which may not be visible in the view of FIG.6C. The leaflets 6602, 6604, and 6606 may be secured to inner liner 6400via stitching 6608 and may include a connector 6610 wrapping around theventricular end delivery posts 2028 to secure the leaflets 6602, 6604,and 6606 to the valve frame 2000.

FIG. 6D illustrates a top plan view of prosthetic valve 6000, withleaflets 6602, 6604, and 6606 arranged in an open, uninflatedconfiguration. In the open configuration, a space may be formed in themiddle of the leaflets, permitting fluid to pass through the axial lumen2022 of the prosthetic valve 6000. FIG. 6E illustrates a top plan viewof prosthetic valve 6000, with leaflets 6602, 6604, and 6606 arranged ina closed, coapted configuration. In the closed configuration, theleaflets may press together such that the opening between them isclosed. For example, the point of contact 6007 between two adjacentleaflets may extend to the center of the axial lumen; as a result, theleaflets may block fluid passage through the axial lumen 2022 of theprosthetic valve 6000.

FIG. 7A illustrates a prosthetic valve delivery system 7000. Deliverysystem 7000 may be configured to deliver an implant prosthetic valve6000 within a native valve, such as a native mitral valve. Prostheticvalve delivery system 7000 may include a control handle assembly 7100, atelescoping catheter assembly 7200, a delivery capsule 7300 configuredto retain a prosthetic valve (e.g. valve 6000), and, optionally, a stand7400.

Control handle assembly 7100 may include an outer sheath control handle7120 having a steering knob 7122 configured to steer an outer sheath7210 of the telescoping catheter assembly 7200. Control handle assembly7100 may also include a guide catheter control handle 7140 having asteering knob 7142 configured to steer a guide catheter 7220 of thetelescoping catheter assembly 7200.

Control handle assembly 7100 may also include an implant cathetercontrol handle 7160 having a steering knob 7168 configured to steer animplant catheter 8100 of the telescoping catheter assembly 7200. Implantcatheter control handle 7160 may also include a proximal capsule portionslider 7162, a distal capsule portion knob 7170, and a distal capsuleportion knob lock 7172 configured to control release of the prostheticvalve 6000 from within delivery capsule 7300. Implant catheter controlhandle 7160 may also include a slide lock 7166 configured to lock theimplant catheter control handle 7160 at a position within track 7420 ofstand 7400.

Control handle assembly 7100 may also include a cradle 7180, which maybe secured to stand 7400 via a locking mechanism that can be released byactuated of release button 7184. Cradle 7180 may include a rotation knob7182 configured to control rotation of the outer sheath 7210 and guidecatheter 7220. Cradle 7180 may also include a rotation knob 7186configured to control rotation of the implant catheter 8100. Cradle 7180may also include a knob 7188 configured to control relative axialmovement between outer sheath control handle 7120 (which may be securedto outer sheath 7210) and guide catheter control handle 7140 (which maybe secured to guide catheter 7220).

FIG. 7B illustrates an enlarged view of delivery capsule 7300 ofprosthetic valve delivery system 7000. Delivery capsule 7300 may includea proximal capsule portion 7320 and a distal capsule portion 7340 with anose cone 7360 secured to the distal capsule portion 7340. A nose conedistal tip 7365 may form the distal end of the delivery capsule 7300.The telescoping catheter assembly 7200 may include a capsule shaft 7230secured to, and configured to control movement of, the proximal capsuleportion 7320 (e.g., due to connection 8400 between the capsule shaft7230 and proximal capsule portion 7320, as illustrated in FIG. 8C).Implant catheter 8100 may extend within proximal capsule portion 7320and may have a valve anchor disc 8200 connected to the distal end of theimplant catheter 8100. A torque shaft 8300 may extend from the implantcatheter 8100 and may be connected to distal capsule portion 7340;accordingly, torque shaft 8300 may be configured to control axialmovement of the distal capsule portion 7340 relative to the implantcatheter 8100 and valve anchor disc 8200. The proximal capsule portion7320 and a distal capsule portion 7340 may be configured to retainprosthetic valve 6000, with the prosthetic valve 6000 secured againstaxial movement by valve anchor disc 8200. Control handle assembly 7100may be configured to control movement of the proximal capsule portion7320 and a distal capsule portion 7340, and thus may also controlrelease of the prosthetic valve 6000 from within the delivery capsule7300.

FIGS. 7C and 7D illustrate exemplary configurations of the telescopingcatheter assembly 7200. Outer sheath 7210 and guide catheter 7220 mayinclude respective bending portions 7215 and 7225, at which the outersheath 7210 and guide catheter 7220 may be configured to bend withintheir respective steering planes 7212 and 7222. In some embodiments,bending of the outer sheath 7210 within the first steering plane 7212may be controlled by the outer sheath steering knob 7122 of the controlhandle assembly 7100. Additionally, or alternatively, bending of theguide catheter 7220 within the second steering plane 7222 may becontrolled by the guide catheter steering knob 7142 of the controlhandle assembly 7100. In some embodiments, under control of the controlhandle assembly 7100, the outer sheath 7210, guide catheter 7220, andimplant catheter 8100 may be steered so as to correctly position thedelivery capsule 7300 within a native valve for implantation of theprosthetic valve.

FIG. 8A illustrates an enlarged view of delivery capsule 7300 in aclosed configuration, while FIG. 8B illustrates an enlarged view ofdelivery capsule 7300 in an open configuration. In the closedconfiguration of FIG. 8A, the distal capsule portion 7340 and proximalcapsule portion 7320 may be brought together to form an enclosedcompartment in which prosthetic valve 6000 may be retained. In the openconfiguration of FIG. 8B, the distal capsule portion 7340 and proximalcapsule portion 7320 may be drawn apart. In some embodiments, thedelivery capsule 7300 may be configured such that the distal capsuleportion 7340 and proximal capsule portion 7320 are moved apart from eachother, the prosthetic valve 6000 may be sequentially deployed fromwithin the delivery capsule and implanted within a native valve.

FIG. 8C illustrates an interior view of delivery capsule 7300 withprosthetic valve 6000 retained within the delivery capsule. Althoughonly the valve frame 2000 of the prosthetic valve 6000 is illustrated inFIG. 8C, one of ordinary skill will understand that the entireprosthetic valve 6000 depicted in FIGS. 6A-6E may be retained withindelivery capsule 7300 in the configuration illustrated in FIG. 8C.

In the embodiment illustrated in FIG. 8C, at least a portion of theannular valve body 2020 and ventricular anchoring legs 2240 of theprosthetic valve 6000 may be retained within the distal capsule portion.Additionally, or alternatively, at least a portion of atrial anchoringarms 2440 may be retained within proximal capsule portion 7320. In someembodiments, valve anchor disc 8200 may include a number of recesses8205 configured to receive and retain the ventricular end delivery posts2028 of the prosthetic valve 6000. For example, the valve anchor disc8200 may include at least the same number of recesses 8205 as there aredelivery posts 2028 of the prosthetic valve 6000. In some embodiments,the delivery posts 2028 may be retained within the recesses 8205 so longas the annular valve body 2020 remains in a radially-contractedconfiguration; the engagement between the valve anchor disc 8200 anddelivery posts 2028 may secure the prosthetic valve 6000 against axialmovement. Upon radial expansion of the annular valve body 2020, thedelivery posts 2028 may slide or expand out of the recesses 8205,freeing the prosthetic valve 6000 from engagement with the valve anchordisc 8200.

FIG. 9 illustrates one exemplary advancement route of the deliverycapsule 7300 to the left atrium. In the example illustrated in FIG. 9,the delivery capsule 7300 may be steered through the vena cava into theright atrium 9210 and may pierce the interatrial septum and enter theleft atrium 9010. Alternatively, the delivery capsule may be deliveredto the heart by other routes. FIG. 9 also depicts the left ventricle9020, the mitral valve 9030, the chordae tendineae 9022, the aorticvalve 9045, and the aorta 9040.

FIGS. 10A-10H depict an exemplary implantation method of prostheticvalve 6000 within a mitral valve 9030. In FIG. 10A, the delivery capsule7300 may be coaxially aligned with the mitral valve 9030. In someembodiments, the prosthetic valve 6000 may be held within the deliverycapsule 7300 while the prosthetic valve is arranged in the configurationof FIG. 5A. In FIG. 10B, the delivery capsule 7300 may be distallyadvanced into the mitral valve 9030. In FIG. 10C, the distal capsuleportion 7340 may be distally advanced relative to the rest of thedelivery capsule 7300. This may release the ventricular anchoring legs2240 from the distal capsule portion 7340, while the atrial anchoringarms 2440 and annular valve body 2020 remain constrained within thedelivery capsule. In the example shown in FIG. 10C, the ventricularanchoring legs 2240 may be released from the delivery capsule 7300within the atrium 9010. In some embodiments, the prosthetic valve 6000may assume the configuration of FIG. 5B when the ventricular anchoringlegs 2240 are released in the step depicted in FIG. 10C.

In FIG. 10D, the released ventricular anchoring legs 2240 may be passedthrough the mitral valve 9030 and into the left ventricle 9020. In FIG.10E, the released legs 2240 may be proximally retracted until theventricular anchoring legs come into contact with the ventricular tissueof the mitral valve 9030. In FIG. 10F, the proximal capsule portion 7320may be retracted proximally, thus releasing the atrial anchoring arms2440 within atrium 9010 while the annular valve body 2020 remainsradially constrained within the distal capsule portion 7340. In someembodiments, the prosthetic valve 6000 may assume the configuration ofFIG. 5D when the atrial anchoring arms 2440 are released in the step ofFIG. 10F.

In FIG. 10G, the distal capsule portion 7340 may be advanced furtheruntil the annular valve body 2020 is released from the capsule andallowed to radially expand. Radial expansion of the annular valve body2020 may allow the prosthetic valve to assume the fully-expandedconfiguration illustrated in FIG. 5E. At this stage, prosthetic valve6000 may be securely implanted within mitral valve 9030. In FIG. 10H,the delivery system 7000, including capsule 7300, may be removed.

Various embodiments of the present disclosure relate to prostheticvalves, including prosthetic heart valves. While the present disclosureprovides examples of prosthetic heart valves, and in particularprosthetic mitral valves, it should be noted that aspects of thedisclosure in their broadest sense are not limited to a prosthetic heartvalve. Rather, the foregoing principles may be applied to otherprosthetic valves as well. Prosthetic heart valve 6000, illustrated inFIGS. 6A-6E, is one example of a prosthetic valve in accordance with thepresent disclosure.

In some embodiments, an exemplary prosthetic valve may be configurationfor implantation within a native atrioventricular valve and may regulateblood flow between the atrium and ventricle. For example, prostheticheart valve 6000 illustrated in FIGS. 6A-6C may include afluid-impervious cuff 6200 configured to extend from an inner lumen 2022of the prosthetic valve to terminal arm ends 2444 of a plurality ofatrial anchoring arms 2440. Because cuff 6200 is constructed of afluid-impervious material, cuff 6200 may be configured to minimize orblock flow of blood and other fluids through any portion of theprosthetic valve 6000 except for lumen 2022. In addition, atrialanchoring arms 2440 of the prosthetic valve (including terminal arm ends2444) may be configured to contact and, in some embodiments, pressagainst atrial tissue of a native heart valve. This is illustrated inFIGS. 10G-10H, which depict atrial anchoring arms 2440 of prostheticvalve 6000 arranged in contact with, and exerting aventricularly-directed force (that is, a force directed downwardstowards ventricle 9020) upon, atrial tissue of native mitral valve 9030.As a result, cuff 6200 of prosthetic valve 6000 may also be configuredto minimize or block passage of blood and other fluids between theprosthetic valve 6000 (including terminal arm ends 2444) and nativevalve tissue, a condition known as perivalvular leakage. As a result,prosthetic valve 6000 may be configured to prohibit passage of blood andother fluids between atrium 9010 and ventricle 9020, except by passagethrough inner lumen 2022, in which leaflets 6602, 6604, and 6606 may besituated.

In some embodiments, an exemplary prosthetic valve may be expandable,such as between a radially-contracted configuration (e.g., a crimpedstate) and a radially-expanded configuration. For example, FIG. 5Aillustrates a radially-contracted configuration of an exemplaryprosthetic valve, and FIG. 5E illustrates a radially-expandedconfiguration of the exemplary prosthetic valve. The diameter of theprosthetic valve, including annular valve body 2020, ventricularanchoring legs 2240, and atrial anchoring arms 2440, may be reduced whenthe prosthetic valve assumes the radially-contracted configuration, asillustrated in FIG. 5A. The diameter of the prosthetic valve may beincreased when the prosthetic valve assumes the radially-expandedconfiguration, as illustrated in FIG. 5E. For example, an annular valvebody 2020 of the prosthetic valve may radially expand when theprosthetic valve assumes the radially-expanded configuration.Additionally, or alternatively, a plurality of ventricular anchoringlegs 2240 and/or atrial anchoring arms 2440 may be configured to deflectradially outward from the exemplary annular valve body 2020 when theprosthetic valve assumes the radially-expanded configuration.

In some embodiments, the exemplary prosthetic valve may be configured tobe radially contracted into a radially-contracted configuration forintroduction to an implantation site, such as on or within a deliverydevice. Accordingly, in some embodiments, the radially-contractedconfiguration may also be a delivery configuration, in which theprosthetic valve is arranged for delivery to the implantation site. Onceat or near the implantation site, the prosthetic valve may be radiallyexpanded to a radially-expanded configuration, in which the prostheticvalve may be anchored at the implantation site. Accordingly, in someembodiments, the radially-expanded configuration may also be a deployedconfiguration, in which the prosthetic valve is released from thedelivery tool and seated at the implantation site.

In some embodiments, an exemplary prosthetic valve may be configured forself-expansion to the radially-expanded configuration; that is, theprosthetic valve may be biased to assume the radially-expandedconfiguration due to, at least in part, the design and/or materialcomposition of the prosthetic valve. The self-expanding prosthetic valvemay be constructed of a shape memory material such as nickel titaniumalloy (Nitinol), which may permit the prosthetic valve to expand to apre-determined diameter upon removal of a constraining force and/orapplication of heat or energy. For example, the prosthetic valve may becontracted and held in the radially-contracted configuration by aconstraining device, such as a sheath, catheter, stent, or deliverycapsule. An example of such a constraining device is illustrated in FIG.8C, which illustrates prosthetic heart valve 6000 held in aradially-contracted configuration within delivery capsule 7300. When theprosthetic valve is positioned at or near the implantation site, theconstraining force may be removed and the prosthetic valve allowed toself-expand to the radially-expanded configuration. Additionally, oralternatively, an exemplary prosthetic valve may be configured to expanddue to application of radially expansive forces thereupon. For example,the prosthetic valve may be placed, in its radially-contractedconfiguration, upon an expansion device such as a balloon catheter. Uponpositioning at the implantation site, the expansion device may exert anoutwardly-directed force upon the prosthetic valve, causing it to expandto the radially-expanded configuration.

In some embodiments, the exemplary prosthetic valve may be configuredfor implantation at a treatment site within the body, such as within oradjacent to a native heart valve structure. In some embodiments, aprosthetic valve may be configured for transcatheter delivery to theimplantation site via a variety of approaches, such as transapically,transatrially, and/or transseptally. In some embodiments, the prostheticvalve may be configured for implantation in the annulus or orifice of anative heart valve structure (e.g., a native heart valve). For example,in FIGS. 10A-10H, prosthetic valve 6000 may be delivered to and expandedwithin native mitral valve 9030 such that prosthetic valve 6000 isanchored within native mitral valve 9030. In some embodiments, theexemplary prosthetic valve may be configured to grasp tissue of thenative heart valve to more firmly anchor the prosthetic valve within thenative heart valve. For example, an exemplary prosthetic valve may beconfigured to grasp the native leaflets and/or native heart valveannulus to firmly seat the prosthetic valve within the valve annulus,thus preventing the prosthetic valve from migrating or dislodging fromwithin the native heart valve annulus.

In some embodiments, the exemplary prosthetic valve may include anannular valve body. The annular valve body may be configured to receiveor otherwise support a flow control device, such as one or moreleaflets, for regulating flow of blood or other bodily fluids throughthe prosthetic valve. For example, the flow control device (e.g.,leaflets) may be secured directly to the annular valve body and/or to anintermediate structure that is in turn secured to the valve body. As aresult, when the prosthetic valve is implanted within a native mitralvalve, the flow control device (e.g., leaflets) may regulate fluidpassage through the native mitral valve, thus restoring and/or replacingthe functionality of the mitral valve. For example, FIGS. 6D and 6Eillustrate an exemplary prosthetic heart valve 6000 including an annularvalve body 2020 with prosthetic leaflets 6602, 6604, and 6606 receivedwithin the annular valve body. In the example of a prosthetic mitralvalve, the flow control device of the annular valve body may beconfigured to permit flow of blood and other fluids in one direction(e.g., from the left atrium to the left ventricle) and to prevent flowof blood and other fluids in a second, opposite direction (e.g., fromthe left ventricle to the left atrium).

In some embodiments, the valve body may be annular or ring-shaped andmay thus have at least one opening within the valve body. In someembodiments, the at least one opening may extend longitudinally alongthe entire length of the annular valve body. For example, FIG. 2Billustrates an exemplary frame 2000 of a prosthetic heart valve. Heartvalve frame 2000 may include an annular valve body 2020 having an axiallumen 2022 extending longitudinally through the annular valve body 2020.The annular valve body may be sized and configured to be seated withinthe orifice of a native mitral valve. For example, as depicted in FIG.10H, annular valve body 2020 may be situated within the orifice ofmitral valve 9030, specifically between native leaflets 9032. In someembodiments, the annular valve body may be configured to have a smallerdiameter, when fully-expanded, than the diameter of the orifice of thenative mitral valve. In such embodiments, the annular valve body may beanchored in the native mitral valve by anchoring structures, such asatrial anchoring arms and/or ventricular anchoring legs. Alternatively,the annular valve body may be configured to expand to an equal orgreater diameter than the diameter of the heart mitral orifice such thatthe annular valve body is anchored within the mitral valve.

The annular valve body may have a circular, oval-shaped, elliptical, orD-shaped cross-section and may be symmetrical about at least one axis ofthe annular valve body. For example, FIG. 2B illustrates exemplaryannular valve body 2020, which may have a substantially circularcross-section and which may be symmetrical about the longitudinal axisof the prosthetic valve. Alternatively, the annular valve body may haveany suitable cross-sectional shape, with at least one opening within theannular valve body. In some embodiments, at least a portion of theannular valve body may be cylindrical, with a substantially constantdiameter along the entire longitudinal length of the annular valve body.Alternatively, the annular valve body may have a variable diameter atdifferent portions of the annular valve body (e.g., at differentlongitudinal portions of the annular valve body). For example, exemplaryannular valve body 2020 illustrated in FIGS. 2A and 2D may have adiameter at a longitudinally central portion of the valve body (that is,in a middle portion of the annular valve body relative to longitudinalaxis 2800) that may be larger than the diameter of the annular valvebody 2020 at the atrial end 2024 of the annular valve body (i.e., thetop of annular valve body 2020 in FIG. 2A) and/or the diameter of theannular valve body 2020 at the ventricular end 2025 of the annular valvebody (i.e., the bottom of annular valve body 2020 in FIG. 2A).Advantageously, such a configuration may improve the seating of theannular valve body within the mitral valve orifice, providing animproved pressure fit therebetween.

In some embodiments, the annular valve body may be configured toradially expand independently of other components of the exemplaryprosthetic valve. For example, the annular valve body may be configuredto remain in a radially-contracted configuration while other componentsof the prosthetic valve, such as one or more tissue anchors, aredeployed radially outward. For example, FIG. 5B depicts an exemplaryannular valve body 2020 arranged in a radially-contracted configurationwhile a plurality of ventricular anchoring legs 2240, and in particularthe terminal leg ends 2244 of the ventricular anchoring legs 2240, aredeployed radially outward (e.g., due to removal of a constrainingdelivery device from the ventricular anchoring legs). In theconfiguration illustrated in FIG. 5B, the heart valve frame 2000 mayadditionally include a plurality of atrial anchoring arms 2440configured in a radially-contracted configuration. Similarly, FIG. 5Cdepicts an exemplary configuration in which the annular valve body 2020and a plurality of ventricular anchoring legs 2240 may be arranged in aradially-contracted configuration, while a plurality of atrial anchoringarms 2440, and in particular the terminal arm ends 2444 of the atrialanchoring arms 2440, are deployed radially outward (e.g., due to removalof a constraining delivery device from the atrial anchoring arms).Further, FIG. 5D depicts an exemplary configuration in which the annularvalve body 2020 may be arranged in a radially-contracted configuration,while the plurality of atrial anchoring arms 2440 and the plurality ofventricular anchoring legs 2240 are deployed radially outward.

In some embodiments, the exemplary prosthetic valve may include aplurality (that is, one or more) of ventricular anchoring legsconfigured to extend radially outward from the annular valve body. Forexample, FIG. 2A illustrates an annular valve body 2020 and a pluralityof ventricular anchoring legs 2240 extending radially outward from theannular valve body. The ventricular anchoring legs may be configured toanchor the prosthetic valve at an implantation site, such as within ornear a native heart valve. For example, the ventricular anchoring legsmay be configured to engage ventricular tissue of a native heart valveto anchor the prosthetic valve within the heart valve. In someembodiments, the ventricular anchoring legs may be configured to bepositioned at least partially within a ventricle upon implantation ofthe prosthetic valve within or near a native heart valve, and to engageventricular tissue of the heart valve. For example, FIGS. 10E-10H depictventricular anchoring legs 2240 of an exemplary prosthetic heart valve6000. Ventricular anchoring legs 2240 are situated within ventricle 9020and may engage the ventricular side of native mitral valve 9030 tosecure prosthetic heart valve 6000 within the mitral valve.

The prosthetic valve may include one ventricular anchoring leg, twoventricular anchoring legs, three ventricular anchoring legs, fourventricular anchoring legs, five ventricular anchoring legs, sixventricular anchoring legs, seven ventricular anchoring legs, eightventricular anchoring legs, nine ventricular anchoring legs, tenventricular anchoring legs, eleven ventricular anchoring legs, twelveventricular anchoring legs, thirteen ventricular anchoring legs,fourteen ventricular anchoring legs, fifteen ventricular anchoring legs,sixteen ventricular anchoring legs, seventeen ventricular anchoringlegs, eighteen ventricular anchoring legs, nineteen ventricularanchoring legs, twenty ventricular anchoring legs, or any other suitablenumber of ventricular anchoring legs. For example, exemplary prostheticvalve 6000 depicted in FIG. 2B includes twelve ventricular anchoringlegs 2240.

In some embodiments, the ventricular anchoring legs may be configured toextend radially outward from the annular valve body to respectiveterminal leg ends. In some embodiments, the term “radially outward” mayrefer to a direction extending away from the center of the annular valvebody (for example, away from the longitudinal axis of the exemplaryprosthetic valve). In some embodiments, the ventricular anchoring legsmay be connected to the annular valve body and configured to extendradially outward from the annular valve body. For example, in FIGS. 5Dand 5E, ventricular anchoring legs 2240 may be connected to annularvalve body 2020 at leg attachment junctions 3802 and may extend radiallyoutward from the annular valve body 2020. In some embodiments, theventricular anchoring legs may be physically connected to the annularvalve body, such as by welding or adhesive. In some alternativeembodiments, the ventricular anchoring legs may be integrally formedwith the annular valve body. In some further alternative embodiments,the ventricular anchoring legs may not be secured directly to theannular valve body; however, the ventricular anchoring legs may beconfigured to extend in a radially outward direction from the annularvalve body.

In some embodiments, the locations of connection between the ventricularanchoring legs and annular valve body may be spaced at a regularinterval about a circumference of the annular valve body. For example,in FIG. 2A, the ventricular anchoring legs 2240 may extend from theannular valve body 2020 at leg attachment junctions 3802. Leg attachmentjunctions 3802 may be spaced at a regular interval about thecircumference of annular valve body 2020. Additionally, oralternatively, the locations of connection between the ventricularanchoring legs and annular valve body may be arranged along a planeperpendicular to the longitudinal axis of the prosthetic valve. Forexample, in FIG. 2A, the leg attachment junctions 3802 may be arrangedalong a plane perpendicular to longitudinal axis 2800. That is, the legattachment junctions 3802 may be situated at the same axial positionalong longitudinal axis 2800.

In some embodiments, each ventricular anchoring leg may include aproximal leg end connected to or otherwise secured relative to theannular valve body, and a terminal leg end configured to extend radiallyoutward from the annular valve body and, thus, from the proximal leg endof the ventricular anchoring leg. In various embodiments, the term“proximal” refers to a portion of a feature (e.g., an ventricularanchoring leg) situated in closest proximity to the annular valve bodyand may, in some embodiments, include a point of connection between thefeature (e.g., the ventricular anchoring leg) and the annular valvebody. In various embodiments, the term “terminal” refers to a portion ofa feature (e.g., an ventricular anchoring leg) furthest from the pointof connection between that feature and the annular valve body. Forexample, ventricular anchoring legs 2240 illustrated in FIGS. 2A and 3Cmay include a proximal leg end 3622 connected to annular valve body 2020(e.g., at leg attachment junction 3802) and a terminal leg end 2244configured to extend radially outward from the annular valve body 2020and from the proximal leg end 3622.

In some embodiments, the exemplary prosthetic valve may include aplurality (that is, one or more) of atrial anchoring arms configured toextend radially outward from the annular valve body. For example, FIG.2A illustrates an annular valve body 2020 and a plurality of atrialanchoring arms 2440 extending radially outward from the annular valvebody. The atrial anchoring arms may be configured to anchor theprosthetic valve at an implantation site, such as within or near anative heart valve. For example, the atrial anchoring arms may beconfigured to engage atrial tissue of a native heart valve to anchor theprosthetic valve within the heart valve. In some embodiments, the atrialanchoring arms may be configured to be positioned at least partiallywithin an atrium upon implantation of the prosthetic valve within ornear a native heart valve, and to engage atrial tissue of the heartvalve. For example, FIGS. 10F-10H depict atrial anchoring arms 2440 ofan exemplary prosthetic heart valve 6000. Atrial anchoring arms 2440 aresituated within atrium 9010 and may engage the atrial side of nativemitral valve 9030 to secure prosthetic heart valve 6000 within themitral valve.

The prosthetic valve may include one atrial anchoring arm, two atrialanchoring arms, three atrial anchoring arms, four atrial anchoring arms,five atrial anchoring arms, six atrial anchoring arms, seven atrialanchoring arms, eight atrial anchoring arms, nine atrial anchoring arms,ten atrial anchoring arms, eleven atrial anchoring arms, twelve atrialanchoring arms, thirteen atrial anchoring arms, fourteen atrialanchoring arms, fifteen atrial anchoring arms, sixteen atrial anchoringarms, seventeen atrial anchoring arms, eighteen atrial anchoring arms,nineteen atrial anchoring arms, twenty atrial anchoring arms, or anyother suitable number of atrial anchoring arms. For example, exemplaryprosthetic valve 6000 depicted in FIG. 2B includes twelve atrialanchoring arms 2440.

In some embodiments, the atrial anchoring arms may be configured toextend radially outward from the annular valve body. In someembodiments, the atrial anchoring arms may be connected to the annularvalve body and configured to extend radially outward from the annularvalve body. For example, in FIGS. 5D and 5E, atrial anchoring arms 2440may be connected to annular valve body 2020 at arm attachment junctions3202 and may extend radially outward from the annular valve body 2020.In some embodiments, the atrial anchoring arms may be physicallyconnected to the annular valve body, such as by welding or adhesive. Insome alternative embodiments, the atrial anchoring arms may beintegrally formed with the annular valve body. In some furtheralternative embodiments, the atrial anchoring arms may not be secureddirectly to the annular valve body; however, the atrial anchoring armsmay be configured to extend in a radially outward direction from theannular valve body.

In some embodiments, the locations of connection between the atrialanchoring arms and annular valve body may be spaced at a regularinterval about a circumference of the annular valve body. For example,in FIG. 2A, the atrial anchoring arms 2440 may extend from the annularvalve body 2020 at arm attachment junctions 3202. Arm attachmentjunctions 3202 may be spaced at a regular interval about thecircumference of annular valve body 2020. Additionally, oralternatively, the locations of connection between the atrial anchoringarms and annular valve body may be arranged along a plane perpendicularto the longitudinal axis of the prosthetic valve. For example, in FIG.2A, the arm attachment junctions 3202 may be arranged along a planeperpendicular to longitudinal axis 2800. That is, the arm attachmentjunctions 3202 may be situated at the same axial position alonglongitudinal axis 2800.

In some embodiments, each atrial anchoring arm may include a proximalarm end connected to or otherwise secured relative to the annular valvebody, and a terminal arm end configured to extend radially outward fromthe annular valve body and, thus, from the proximal arm end of theatrial anchoring arm. For example, atrial anchoring arms 2440illustrated in FIGS. 2A and 3A may include a proximal arm end 3020connected to annular valve body 2020 (e.g., at arm attachment junction3202) and a terminal arm end 2444 configured to extend radially outwardfrom the annular valve body 2020 and from the proximal arm end 3020.

In some embodiments, at least one atrial anchoring arm may include aproximal arm portion, an intermediate arm portion, and a distal armportion. For example, FIG. 3B illustrates an exemplary atrial anchoringarm 2440 having a proximal arm portion 3502, an intermediate arm portion3504, and a distal arm portion 3506. In some embodiments, the proximalarm portion 3502 may be configured to extend in an atrial direction fromarm attachment junction 3202 (not depicted in FIG. 3B). Arm attachmentjunctions may be the locations at which atrial anchoring arms 2440attach to the annular valve body 2020. In some embodiments, and asillustrated in FIG. 3B, the entire length of proximal arm portion 3502may be configured to extend in an atrial direction (i.e., in an upwarddirection in FIG. 3B). Atrial anchoring arm 2440 may include a bend at atransition between proximal arm portion 3502 and intermediate armportion 3504. As a result, in some embodiments, intermediate arm portion3504 may be configured to extend in a ventricular direction (i.e., in adownward direction in FIG. 3B). In some alternative embodiments, theintermediate arm portion 3504 may be configured to extend laterally suchthat the intermediate arm portion 3504 does not extend in an atrialdirection or in a ventricular direction. Atrial anchoring arm 2440 mayinclude a second bend at the transition between intermediate arm portion3504 and distal arm portion 3506. As a result, in some embodiments,distal arm portion 3506 may be configured to extend in an atrialdirection. In some embodiments, a width of the proximal arm portion 3502may be substantially equal to the width of at least a portion of theintermediate arm portion 3504 (the width being a dimension of the atrialanchoring arm that is perpendicular to the longitudinal axis of theprosthetic valve). Additionally, or alternatively, and as illustrated inFIG. 3B, a radially outer end of the intermediate arm portion 3504 (thatis, the end of intermediate arm portion 3504 furthest from the annularvalve body 2020) may have a larger width than a radially inner end ofthe intermediate arm portion 3504. Additionally, or alternatively, andas illustrated in FIG. 3B, distal arm portion 3506 may have a largerwidth than proximal arm portion 3502.

In some embodiments, the atrial anchoring arms and ventricular anchoringlegs may be configured to minimize or prevent migration of theprosthetic valve into an adjacent heart chamber after the prostheticvalve is implanted within or near a native heart valve. This may be due,at least in part, to the diameter of the atrial anchoring arms and/orthe ventricular anchoring legs when they are radially-expanded. That is,the distal ends of the atrial anchoring arms and/or the distal ends ofthe ventricular anchoring legs may form a circumference having adiameter, when in the radially-expanded configuration, the diameter ofthe circumference being larger than the diameter of the heart valveorifice; accordingly, the prosthetic valve may be prevented from axialmigration (that is, migration towards the atrium or ventricle) due tothe inability of the atrial anchoring arms and/or the ventricularanchoring legs to pass through the valve orifice. Additionally, oralternatively, the atrial anchoring arms and ventricular anchoring legsmay be configured to grasp or clamp tissue of the native heart valve tofurther anchor the prosthetic valve in place. For example, in theembodiment of FIGS. 10G and 10H, atrial anchoring arms 2440 may clamptissue by exerting a ventricularly-directed force (that is, a forcedirected downwards towards ventricle 9020 in FIGS. 10G and 10H) on theheart valve tissue. Similarly, ventricular anchoring legs 2240 may clampthe tissue by exerting an atrially-directed force (that is, a forcedirected upwards towards atrium 9010 in FIGS. 10G and 10H) on the heartvalve tissue. These opposing forces may clamp or “sandwich” the heartvalve tissue between the atrial anchoring arms and ventricular anchoringlegs, thus firmly anchoring prosthetic heart valve 6000 within thenative heart valve.

In some embodiments, the atrial anchoring arms and ventricular anchoringlegs may be constructed of one or more materials, such as a polymer ormetal. The one or more materials may be biocompatible and, in someembodiments, may have shape-memory and superelastic properties. Forexample, the atrial anchoring arms and ventricular anchoring legs may beconstructed at least partially of Nitinol, stainless steel, chromiumalloys, or another other suitable material. In some embodiments, theannular valve body, plurality of atrial anchoring arms, and plurality ofventricular anchoring legs may be constructed substantially of the samematerial (e.g. Nitinol).

In some embodiments, each atrial anchoring arm may include a graspingsegment situated within a radially inner portion of the atrial anchoringarm. In some embodiments, the grasping segment may extend between theproximal end of the atrial anchoring arm and a midpoint of the atrialanchoring arm. For example, in FIG. 3B, inflexible portion 3402 mayconstitute the grasping segment. Inflexible portion 3402 may include atleast a portion of the proximal arm portion 3502 and at least a portionof the intermediate arm portion 3504; for example, the inflexibleportion 3402 may extend to, and may optionally include, the proximal armend 3020. In some embodiments, the grasping segment may be configuredwith a sufficiently large cross-sectional area, such that the graspingsegment may be substantially rigid and inflexible. For example, theinflexible portion 3402 illustrated in FIG. 3B may be configured with asufficiently large cross-sectional area 3402 c, such that the inflexibleportion 3402 is substantially rigid and inflexible.

Additionally, or alternatively, each atrial anchoring arm may include ananchoring segment situated within a radially outer portion of the atrialanchoring arm. The anchoring segment may be configured to be situatedradially external to the grasping segment and may be configured forgreater flexibility than the grasping segment. For example, in FIG. 3B,serpentine structure 3406 may constitute the anchoring segment.Serpentine structure 3406 may include at least a portion of theintermediate arm portion 3504 and at least a portion of the distal armportion 3506. In some embodiments, the anchoring segment may include astructure having multiple curves, the structure being configured torender the anchoring segment substantially flexible. For example, insome embodiments, the structure having multiple curves may include aserpentine pattern, such as serpentine structure 3406 illustrated inFIG. 3B. The structure having multiple curves (e.g., serpentinestructure 3406) may include a thin section of the atrial anchoring armconfigured to curve back and forth in a zig-zagging arrangement. Thisconfiguration may render the serpentine structure 3406 flexible andelastic (in particular, more flexible and elastic than the inflexibleportion 3402 of the atrial anchoring arm). In some embodiments, theanchoring segment may be less resistive to applied forces, compared tothe grasping segment, due at least in part to the thin cross-section andthe zig-zagging arrangement of the structure having multiple curves.However, the anchoring segment may be constructed of a superelasticmaterial such as Nitinol; as a result, the anchoring segment may beconfigured to resist being deformed or damaged by the forces applied tothe anchoring segment by the native valve tissue.

In some embodiments, the grasping segment may be situated immediatelyadjacent to, and radially inward from, the anchoring segment, along thelength of the atrial anchoring arm. For example, in FIG. 3B, location3402 d may be the transition between inflexible portion 3402 (i.e., theexemplary grasping segment) and serpentine structure 3406 (i.e., theexemplary anchoring segment). Accordingly, the flexibility of the atrialanchoring arm 2440 may vary at 3402 d, because serpentine structure 3406may be configured for greater flexibility than inflexible portion 3402.

In some embodiments, the distal ends of the grasping segments of theatrial anchoring arms may be configured to be situated at the sameradial position, or at a similar radial position, as the terminal endsof the ventricular anchoring legs. For example, the distal ends 3402 dof the inflexible portions 3402 (i.e., the exemplary grasping segments)and the terminal leg ends 2244 may be configured to be substantiallyequidistant from the center of the annular valve body 2020 (i.e., fromlongitudinal axis 2800 of FIGS. 2A and 2D) when the prosthetic valve isin a radially-expanded configuration. Alternatively, the distal ends3402 d of the inflexible portions 3402 may be configured to be situatedradially inward from, or radially external to, the terminal leg ends2244 when the prosthetic valve is in a radially-expanded configuration.However, the distance between longitudinal axis 2800 and locations 3402d (i.e., the distal ends of the inflexible portions 3402) and thedistance between longitudinal axis 2800 and terminal leg ends 2244 maydiffer by a distance equal to or less than three (3) millimeters, whenthe prosthetic valve is in a radially-expanded configuration. As aresult, the terminal leg ends 2244 of the ventricular anchoring legs andthe distal ends 3402 d of the inflexible portions 3402 of the atrialanchoring arms may be situated at the same radial position, or atsimilar radial positions, when the prosthetic valve is implanted. Insome embodiments, the distance between longitudinal axis 2800 andlocations 3402 d and the distance between longitudinal axis 2800 andistal leg ends 2244 may differ by approximately one (1) millimeter,while in some embodiments the difference may be approximately two (2)millimeters.

In some embodiments, the ventricular anchoring legs and the graspingsegments of the atrial anchoring arms may be configured to substantiallyrestrict axial movement of the annular valve body within the nativeheart valve. Because the terminal leg ends and the distal ends of thegrasping segments of the atrial anchoring arms may be situated at thesame radial position, or at similar radial positions, when theprosthetic valve is implanted, the ventricular anchoring legs and thegrasping segments of the atrial anchoring arms may be configured tofirmly grasp tissue between them by exerting opposing forces upon thetissue. For example, the ventricular anchoring legs may engage theventricular side of native valve tissue, and may exert anatrially-directed force (that is, a force directed upwards towards theatrium) on the heart valve tissue. In addition, the atrial anchoringarms may engage the atrial side of native valve tissue; thus, thegrasping segments may exert a ventricularly-directed force (that is, aforce directed downwards towards the ventricle) on the heart valvetissue. An example of this configuration is illustrated in FIGS. 10G and10H, which depict atrial anchoring arms 2440 and ventricular anchoringlegs 2240 engaging atrial tissue and ventricular tissue, respectively,of mitral valve 9030, so as to clamp the mitral valve tissue betweenthem. Additionally, the placement of the structures that exert theopposing forces (i.e., the ventricular anchoring legs and the graspingsegments of the atrial anchoring arms) at the same radial position or atsimilar radial positions may strengthen the clamping force, as theatrially-directed force and ventricularly-directed force may directlyoppose one another. As a result, the ventricular anchoring legs and thegrasping segments may firmly anchor the exemplary prosthetic heart valvewithin the native heart valve, thus securing the annular valve bodyagainst axial movement (including movement towards the atrium andventricle) and lateral movement (that is, side-to-side movement of theannular valve body) relative to the tissue grasped between theventricular anchoring legs and the grasping segments.

Additionally, or alternatively, the anchoring segments of the atrialanchoring arms may be configured for lateral deformation relative to thenative heart valve. For example, the flexibility of the anchoringsegments (e.g., due to serpentine structure 3406) may enable theanchoring segments to contact and be deformed by the anatomy of thenative heart valve. That is, the flexible anchoring segments may bedeformed, both laterally and axially, until the anchoring segmentsconform to the anatomy of the native valve. By conforming to the nativevalve anatomy, the anchoring segments may increase the surface area ofnative valve tissue that is engaged by the atrial anchoring arms,further securing the prosthetic valve against axial migration. Inaddition, the flexibility of the anchoring segments may enable theanchoring segments to accommodate the natural motion of the native heartvalve, without the atrial anchoring arms sustaining damage or injuringthe native valve tissue over time. Further, because the anchoringsegments (e.g., serpentine structure 3406) may be positioned in asection of the atrial anchoring arms external to the grasping segments(e.g., inflexible portion 3402), the atrial anchoring arms may beconfigured to exert the clamping force on tissue (via inflexibleportions 3402) while also securing the prosthetic valve against axialmigration (via serpentine structures 3406).

In some embodiments, and as explained above, each atrial anchoring armmay include a grasping segment (e.g., inflexible portion 3402) and ananchoring segment (e.g., serpentine structure 3406). Additionally, oralternatively, each ventricular anchoring leg may be devoid ofstructures configured to render the legs flexible, including serpentinestructure 3406. As a result, the plurality of atrial anchoring arms andthe plurality of ventricular anchoring legs may be arranged in asymmetrical fashion about the annular valve body, because each atrialanchoring arm may be identically configured and each ventricularanchoring leg may be identically configured. As a result, the annularvalve body may be configured to be implanted in the native heart valveindependent of the rotational position of the atrial anchoring arms andventricular anchoring legs relative to the native heart valve. That is,because the atrial anchoring arms and ventricular anchoring legs may besymmetrically arranged, the arms and legs may be configured to grasp thenative valve tissue and anchor the prosthetic valve within the nativevalve against axial migration (as discussed above), at any rotationalrelationship between the prosthetic valve and the native valve.Advantageously, this may simplify the implantation process of theprosthetic valve enormously, since the prosthetic valve does not need tobe implanted at any specific rotational position within the nativevalve.

In some embodiments, the anchoring segments of the atrial anchoring armsmay be configured for greater flexibility than the ventricular anchoringlegs and the grasping segments of the atrial anchoring arms. In someembodiments, the anchoring segments of the atrial anchoring arms mayinclude a structure having multiple curves that may be configured torender the anchoring segments substantially flexible. For example, asillustrated in FIG. 3B, serpentine structure 3406 (i.e., the exemplaryanchoring segment) may include a thin, zig-zagging structure configuredto render the anchoring segment substantially flexible. As alsoillustrated in FIGS. 3B and 3D, ventricular anchoring legs 2240 andgrasping segments 3402 (i.e., the exemplary inflexible portions) of theatrial anchoring arms 2440 may be devoid of a serpentine structure, orany other structure configured to render the legs and grasping segmentsas flexible as the anchoring segments.

In some embodiments, the flexibility of each ventricular anchoring legmay be substantially the same. This may be due to the fact that theplurality of ventricular anchoring legs may be devoid of a serpentinestructure 3406, or any other structure configured to render certainventricular anchoring legs more flexible than others. In addition, insome embodiments, the ventricular anchoring legs may be constructed ofthe same material (e.g., Nitinol) and may be substantially similar inshape and dimensions, such that the ventricular anchoring legs may beconfigured to have substantially the same flexibility.

In some embodiments, a portion of at least one atrial anchoring arm maybe configured to be substantially aligned in a common lateral plane witha portion of at least one ventricular anchoring leg. That is, the atleast one atrial anchoring arm and at least one ventricular anchoringleg may assume a configuration in which a portion of the atrialanchoring arm and a portion of the ventricular anchoring leg aresituated at the same axial position along the longitudinal axis of theprosthetic valve. An example of such a configuration is illustrated inFIG. 2C, which depicts at least one ventricular anchoring leg 2240having a portion 2246 aligned in a common lateral plane with a portion2446 of at least one atrial anchoring arm 2440, the common lateral planebeing perpendicular to the longitudinal axis 2800 illustrated in FIG.2A. That is, leg portion 2246 and arm portion 2446 (as pictured in FIG.2C) may be situated at the same axial position along longitudinal axis2800. In some embodiments, atrial anchoring arms 2440 and ventricularanchoring legs 2240 may be biased to assume the configurationillustrated in FIG. 2C (e.g., due to the shape-memory properties of thearms and legs). In some embodiments, the portion of the at least oneatrial anchoring arm that is arranged in the common lateral plane (e.g.,portion 2446 in FIG. 3C) may be situated in an outer radial half of theat least one atrial anchoring arm.

In some embodiments, the atrial anchoring arms and ventricular anchoringlegs may be biased to assume a certain configuration, such as theconfiguration illustrated in FIG. 2C. However, upon implantation of theprosthetic valve, the valve may grasp and retain native valve tissuebetween the atrial anchoring arms and ventricular anchoring legs. Forexample, FIGS. 10G and 10H illustrate tissue of mitral valve 9030retained between atrial anchoring arms 2440 and ventricular anchoringlegs 2240. The retained tissue may slightly deform the atrial anchoringarms 2440 and ventricular anchoring legs 2240, pushing the arms and legsaxially apart from each other (and thus, out of the configurationillustrated in FIG. 2C). However, due to their shape memorycharacteristics, the grasping segments 3402 of the atrial anchoring armsand the ventricular anchoring legs 2240 may resist the deformation andexert their respective clamping forces on the retained tissue. Forexample, grasping segments 3402 may clamp tissue by exerting aventricularly-directed force (that is, a force directed downwards towardventricle 9020 in FIGS. 10G and 10H) on the heart valve tissue.Similarly, ventricular anchoring legs 2240 may clamp the tissue byexerting an atrially-directed force (that is, a force directed upwardstoward atrium 9010 in FIGS. 10G and 10H) on the heart valve tissue. Theopposing forces exerted by the grasping segments and ventricularanchoring legs may clamp or “sandwich” the heart valve tissue betweenthe atrial anchoring arms and ventricular anchoring legs, thus firmlyanchoring prosthetic heart valve 6000 against axial and lateral movementwithin the native heart valve.

In some embodiments, at least the majority of the anchoring segment ofthe at least one atrial anchoring arm may be configured to be situatedradially external to the portion of the at least one atrial anchoringarm aligned in the common lateral plane. In the example illustrated inFIG. 2C, the entirety of serpentine structure 3406 (i.e., the exemplaryanchoring segment) is situated radially external to arm portion 2446,which is aligned in a common lateral plane with leg portion 2246. Insome alternative embodiments, a portion of the anchoring segment may besituated radially internal of the portion of the at least one atrialanchoring arm aligned in the common lateral plane.

In some embodiments, the grasping segment of at least one atrialanchoring arm may be configured to have a length substantially equal toa length of at least one ventricular anchoring leg. In some embodiments,the length of the grasping segment and the length of the at least oneventricular anchoring leg may extend in directions perpendicular to thelongitudinal axis of the prosthetic valve. For example, in FIG. 2E,length 2581 may represent the length of the grasping segment (i.e.,inflexible portion 3402 illustrated in FIG. 3B) and length 2590 mayrepresent the length of the ventricular anchoring legs 2240. BecauseFIG. 2E illustrates a top plan view of valve frame 2000, lengths 2581and 2590 may be perpendicular to longitudinal axis 2800 in FIG. 2D. Insome embodiments, length 2581 of the grasping segment may be equal tolength 2590 of the ventricular anchoring legs. In some alternativeembodiments, length 2581 of the grasping segment may be longer thanlength 2590 of the ventricular anchoring legs. For example, length 2581may be between zero (0) millimeters and three (3) millimeters longerthan length 2590. In some further alternative embodiments, length 2581of the grasping segment may be shorter than length 2590 of theventricular anchoring legs. For example, length 2581 may be between zero(0) millimeters and three (3) millimeters shorter than length 2590.

In some embodiments, the ventricular anchoring legs may have a length ofbetween six (6) millimeters and 12 millimeters. The length of theventricular anchoring legs may be a length extending between theproximal leg end (e.g., proximal leg end 3622) and the terminal leg end(e.g., terminal leg end 2244), in a direction perpendicular to thelongitudinal axis of the prosthetic valve (as represented by length 2590in FIG. 2E). For example, and without limitation, the ventricularanchoring legs may have a length of 6 millimeters, 6.5 millimeters, 7millimeters, 7.5 millimeters, 8 millimeters, 8.5 millimeters, 9millimeters, 9.5 millimeters, 10 millimeters, 10.5 millimeters, 11millimeters, 11.5 millimeters, 12 millimeters, or any other suitablelength.

In some embodiments, the grasping segments of the atrial anchoring arms(e.g., inflexible portions 3402) may have a length of between six (6)millimeters and 12 millimeters. The length of the grasping segments maybe a length extending between a proximal arm end (e.g., proximal arm end3020) and a distal end of the inflexible portion of the arm 3402 d, asillustrated in FIG. 3B, the length extending in a directionperpendicular to the longitudinal axis of the prosthetic valve (asrepresented by length 2581 in FIG. 2E). For example, and withoutlimitation, the grasping segments may have a length of 6 millimeters,6.5 millimeters, 7 millimeters, 7.5 millimeters, 8 millimeters, 8.5millimeters, 9 millimeters, 9.5 millimeters, 10 millimeters, 10.5millimeters, 11 millimeters, 11.5 millimeters, 12 millimeters, or anyother suitable length.

In some embodiments, the grasping segment of at least one atrialanchoring arm may include a first portion configured to extend in anatrial direction. Additionally, or alternatively, the grasping segmentof the at least one atrial anchoring arm may include a second portionconfigured to extend in a ventricular direction, the second portion ofthe grasping segment configured to be situated radially external to thefirst portion of the grasping segment. In the example illustrated inFIG. 3B, inflexible portion 3402 (i.e., the exemplary grasping segment)may include proximal arm portion 3502 and a portion of intermediate armportion 3504. In some embodiments, and as illustrated in FIG. 3B, theentire length of proximal arm portion 3502 may be configured to extendin an atrial direction (i.e., in an upward direction in FIG. 3B). Atrialanchoring arm 2440 may include a bend at a transition between proximalarm portion 3502 and intermediate arm portion 3504. As a result,intermediate arm portion 3504 may be configured to extend in aventricular direction (i.e., in a downward direction in FIG. 3B).Intermediate arm portion 3504 may be situated radially external toproximal arm portion 3502 when the atrial anchoring arm 2440 is in aradially-expanded configuration.

In some embodiments, the anchoring segment of at least one atrialanchoring arm may include a first portion configured to extend in aventricular direction. Additionally, or alternatively, the anchoringsegment of the at least one atrial anchoring arm may include a secondportion configured to extend in an atrial direction, the second portionof the anchoring segment configured to be situated radially external tothe first portion of the anchoring segment. In the example illustratedin FIG. 3B, serpentine structure 3406 (i.e., the exemplary anchoringsegment) may include a portion of intermediate arm portion 3504 and aportion of distal arm portion 3506. Intermediate arm portion 3504 may beconfigured to extend in a ventricular direction (i.e., in a downwarddirection in FIG. 3B). Atrial anchoring arm 2440 may include a bend atthe transition between intermediate arm portion 3504 and distal armportion 3506. As a result, in some embodiments, distal arm portion 3506may be configured to extend in an atrial direction. Distal arm portion3506 may be situated radially external to intermediate arm portion 3504when the atrial anchoring arm 2440 is in a radially-expandedconfiguration.

In some embodiments, an entire length of at least one ventricularanchoring leg may be configured to extend in an atrial direction. Theentire length of the at least one ventricular anchoring leg may refer tothe leg portions extending between, and including, proximal leg end 3622and terminal leg end 2244. In some embodiments, the entire length of theat least one ventricular anchoring leg may be configured to extend in anatrial direction when the leg is in a radially-contracted configuration.For example, as depicted in FIG. 5A, the entire length of ventricularanchoring leg 2240 (including proximal leg end 3622 and terminal leg end2244) extends in an atrial direction when the ventricular anchoring legis in the radially-contracted configuration. Additionally, oralternatively, the entire length of the at least one ventricularanchoring leg may be configured to extend in an atrial direction whenthe ventricular anchoring leg is in a radially-expanded configuration.For example, as depicted in FIGS. 3C and 5E, the entire length ofventricular anchoring leg 2240 (including proximal leg end 3622 andterminal leg end 2244) extends in an atrial direction when theventricular anchoring leg is in the radially-expanded configuration.

In some embodiments, the ventricular anchoring legs may be angularlyoffset from the atrial anchoring arms. That is, the atrial anchoringarms and ventricular anchoring legs may be situated at differentrotational positions about the circumference of the annular valve body.For example, in FIG. 2B, each atrial anchoring arm 2440 and eachventricular anchoring leg 2240 may be situated at a different angularposition about the circumference of annular valve body 2020. In someembodiments, the atrial anchoring arms may alternate with theventricular anchoring legs about the circumference of the annular valvebody. Additionally, or alternatively, the atrial anchoring arms may beangularly offset at a regular interval from the ventricular anchoringlegs.

In some embodiments, the terminal arm ends of the atrial anchoring armsmay be configured to be situated radially external to the terminal legends. That is, the terminal arm ends of the atrial anchoring arms may besituated further away from the longitudinal axis of the prosthetic valvethan the terminal leg ends of the ventricular anchoring legs. By way ofexample in FIG. 2E, atrial anchoring arms 2440 may be configured toextend radially outward such that the terminal arm ends 2444 form anatrial anchoring arm circumference 2640. Similarly, ventricularanchoring legs 2240 may be configured to extend radially outward suchthat the terminal leg ends 2244 form a ventricular anchoring legcircumference 2620. As illustrated in FIG. 2E, the atrial anchoring armcircumference 2640 may have a larger radius than the ventricularanchoring leg circumference 2620.

In some embodiments, the atrial anchoring arms may be configured forradial movement, such as between the radially-contracted configurationillustrated in FIG. 5A and the radially-expanded configurationillustrated in FIG. 5E. In addition, the prosthetic valve may be devoidof connections between the atrial anchoring arms, other than thelocations where the atrial anchoring arms connect to the annular valvebody. For example, in FIG. 2A, the atrial anchoring arms 2440 may notinclude any interconnections, other than the connections of the arms tothe annular valve body 2020 at arm attachment junctions 3202. As aresult, at least one atrial anchoring arm may be configured for radialmovement independent of the other atrial anchoring arms. For example, asthe at least one atrial anchoring arm moves radially (e.g., between theradially-contracted and radially-expanded configurations), the otheratrial anchoring arms may remain stationary, because they are notinterconnected with the at least one atrial anchoring arm.

Advantageously, the atrial anchoring arms free of interconnections maybe configured in a smaller diameter when the atrial anchoring arms areradially-contracted, as compared to atrial anchoring arms withinterconnections. For example, FIG. 5A illustrates an embodiment inwhich atrial anchoring arms 2440 are arranged in a radially-contractedconfiguration and are free of interconnections beyond arm attachmentjunctions 3202. In this configuration, the atrial anchoring arms 2440may be arranged parallel to the longitudinal axis of the prostheticvalve, and may be devoid of portions extending radially outwards fromannular valve body 2020. As a result, the exemplary prosthetic heartvalve illustrated in FIG. 5A may be configured to assume a smalldiameter when radially-contracted, allowing for the prosthetic heartvalve to be contained within a delivery device with a small diameter. Incomparison, atrial anchoring arms with interconnections beyond theattachment locations may be unable to assume the configurationillustrated in FIG. 5A, because the interconnections between the atrialanchoring arms may prevent the atrial anchoring arms from being situatedas close together as they are in the configuration of FIG. 5A. As aresult, the diameter of the radially-contracted arms, and thus thediameter of the delivery device, would be increased as a result ofinterconnections between the atrial anchoring arms.

Additionally, or alternatively, the ventricular anchoring legs may beconfigured for radial movement, such as between the radially-contractedconfiguration illustrated in FIG. 5A and the radially-expandedconfiguration illustrated in FIG. 5E. In addition, the prosthetic valvemay be devoid of connections between the ventricular anchoring legs,other than the locations where the ventricular anchoring legs connect tothe annular valve body. For example, in FIG. 2A, the ventricularanchoring legs 2240 may not include any interconnections, other than theconnections of the legs to the annular valve body 2020 at leg attachmentjunctions 3802. As a result, at least one ventricular anchoring leg maybe configured for radial movement independent of the other ventricularanchoring legs. For example, as the at least one ventricular anchoringleg moves radially (e.g., between the radially-contracted andradially-expanded configurations), the other ventricular anchoring legsmay remain stationary since they are not interconnected with the atleast one ventricular anchoring leg.

Advantageously, the ventricular anchoring legs free of interconnectionsmay also be configured in a smaller diameter when the ventricularanchoring legs are radially-contracted, as compared to ventricularanchoring legs having interconnections. For example, FIG. 5A illustratesan embodiment in which ventricular anchoring legs 2240 are arranged in aradially-contracted configuration and are free of interconnectionsbeyond leg attachment junctions 3802. In this configuration, theventricular anchoring legs 2240 may be positioned adjacent to, or mayoptionally be in contact with, the inner frame tubular portion 3005. Asa result, the exemplary prosthetic heart valve illustrated in FIG. 5Amay be configured to assume a small diameter when radially-contracted,allowing for the prosthetic heart valve to be contained within adelivery device with a small diameter. In comparison, ventricularanchoring legs having interconnections beyond the attachment locationsmay be unable to assume the small diameter illustrated in FIG. 5A,because the interconnections between the ventricular anchoring legs mayprevent the ventricular anchoring legs from being situated as closetogether as the ventricular legs are situated in the configuration ofFIG. 5A. As a result, the diameter of the radially-contractedventricular anchoring legs, and thus, the diameter of the deliverydevice, would be increased as a result of interconnections between theventricular anchoring legs.

In some embodiments, the annular valve body may include an atrial end.In some embodiments, the atrial end may refer to the portion of theannular valve body configured to be situated at a location within theatrium that is furthest from an adjacent ventricle, when the exemplaryprosthetic valve is implanted in a native heart valve. For example, asdepicted in FIG. 2A, atrial end inner frame junctions 3002 mayconstitute the atrial end 2024 of exemplary annular valve body 2020because the atrial end inner frame junctions 3002 are the portions ofannular valve body 2020 that are situated within atrium 9010 at alocation furthest from ventricle 9020 (as shown in FIG. 10H).

In some embodiments, the annular valve body may include a ventricularend opposite the atrial end of the annular valve body. In someembodiments, the ventricular end may refer to the portion of the annularvalve body configured to be situated at a location within the ventriclethat is furthest from an adjacent atrium, when the prosthetic valve isimplanted in a native heart valve. The ventricular end of the annularvalve body may constitute an opposite end of the annular valve body fromthe atrial end. For example, in some embodiments and as depicted in FIG.2A, ventricular end inner frame junctions 3004 and ventricular end outerframe junctions 3604 may constitute the ventricular end 2025 of annularvalve body 2020, because junctions 3004 and 3604 are the portions ofannular valve body 2020 that are situated within ventricle 9020 at alocation furthest from atrium 9010 (as shown in FIG. 10H). In someembodiments, the ventricular end inner frame junctions 3004 (i.e., theexemplary ventricular end of inner frame 2400) and the ventricular endouter frame junctions 3604 (i.e., the exemplary ventricular end of outerframe 2200) may be evenly aligned within a plane perpendicular tolongitudinal axis 2800. That is, the ventricular end inner framejunctions 3004 and the ventricular end outer frame junctions 3604 may besituated at the same axial position along longitudinal axis 2800. Insome alternative embodiments, the ventricular end inner frame junctions3004 may constitute the ventricular end 2025 of annular valve body 2020.In some further alternative embodiments, the ventricular end outer framejunctions 3604 may constitute the ventricular end 2025 of annular valvebody 2020.

In some embodiments, the annular valve body may include an intermediateportion extending between the atrial end and ventricular end of theannular valve body. In some embodiments, the intermediate portion of theannular valve body may constitute every portion of the annular valvebody situated in between the atrial end of the annular valve body andthe ventricular end of the annular valve body. For example, as depictedin FIG. 2A, intermediate portion 2026 of annular valve body 2020 mayinclude every portion of the annular valve body positioned betweenatrial end 2024 and ventricular end 2025.

In some embodiments, the atrial anchoring arms and the ventricularanchoring legs may be configured to extend from the intermediate portionof the annular valve body. That is, the locations of connection betweenthe atrial anchoring arms and annular valve body, as well as thelocations of connection between the ventricular anchoring legs andannular valve body, may be situated within the intermediate portion ofthe annular valve body. For example, as illustrated in FIG. 2A, armattachment junctions 3202 (from which atrial anchoring arms 2440 extend)and leg attachment junctions 3802 (from which ventricular anchoring legs2240 extend) are situated in the intermediate portion 2026 of annularvalve body 2020, and are accordingly spaced apart from the atrial end2024 and ventricular end 2025 of the annular valve body. In someembodiments, the arm attachment junctions 3202 may be situated in anatrial direction relative to the leg attachment junctions 3802.

In some embodiments, the annular valve body may include an atrial inletopening at the atrial end of the annular valve body. The atrial inletopening may be an opening or aperture at the atrial end of the axiallumen of the annular valve body. For example, in FIG. 2A, annular valvebody 2020 includes an atrial inlet opening 2032, which may be an openingat the atrial end of axial lumen 2022 (illustrated in FIG. 2B). In someembodiments, the atrial inlet opening may be configured as an opening oraperture through which blood or other fluid within the atrium may enterthe axial lumen of the annular valve body. The blood or other fluid mayflow along the axial lumen and exit into the ventricle. In someembodiments, the atrial inlet opening may be bounded by the innersurface of the atrial end of the annular valve body. For example, inFIG. 2D, atrial inlet opening 2032 may be bounded by inner surface 4020of atrial end inner frame junctions 3002, which may form the atrial endof annular valve body 2020. Longitudinal axis 2800 may extend throughthe center of atrial inlet opening 2032.

In some embodiments, the atrial inlet opening of the annular valve bodymay have a radius of between 10 millimeters and 16 millimeters. Length2520 depicted in FIG. 2D represents the radius of the atrial inletopening 2032. For example, and without limitation, the atrial inletopening of the annular valve body may have a radius of 10 millimeters,10.5 millimeters, 11 millimeters, 11.5 millimeters, 12 millimeters, 12.5millimeters, 13 millimeters, 13.5 millimeters, 14 millimeters, 14.5millimeters, 15 millimeters, 15.5 millimeters, 16 millimeters, or anyother suitable radius length.

In some embodiments, at least one atrial anchoring arm may be configuredto have a length larger than the radius of the atrial inlet opening ofthe annular valve body. In some embodiments, the length of the at leastone atrial anchoring arm may extend in a direction perpendicular to thelongitudinal axis of the prosthetic valve. For example, in FIG. 2E,length 2580 may represent the length of the atrial anchoring arms 2440.Because FIG. 2E illustrates a top plan view of valve frame 2000, length2580 may be perpendicular to longitudinal axis 2800 in FIG. 2D. In someembodiments, length 2580 of at least one atrial anchoring arm 2440 maybe longer than the radius 2520 of atrial inlet opening 2032, illustratedin FIG. 2D.

In some embodiments, the atrial anchoring arms may have a length ofbetween 12 millimeters and 18 millimeters. The length of the atrialanchoring arms may be a length extending between the proximal arm end(e.g., proximal arm end 3020) and the terminal arm end (e.g., terminalarm end 2444), in a direction perpendicular to the longitudinal axis ofthe prosthetic valve (as represented by length 2580 in FIG. 2E). Forexample, and without limitation, the atrial anchoring arms may have alength of 12 millimeters, 12.5 millimeters, 13 millimeters, 13.5millimeters, 14 millimeters, 14.5 millimeters, 15 millimeters, 15.5millimeters, 16 millimeters, 16.5 millimeters, 17 millimeters, 17.5millimeters, 18 millimeters, or any other suitable length.

In some embodiments, the exemplary prosthetic valve may include anannular outer frame and an inner frame situated at least partiallywithin the annular outer frame. In some embodiments, one or both of theinner frame and the outer frame may be annular, and the inner frame maybe positioned within an opening of the outer frame. For example, FIG. 2Adepicts an exemplary prosthetic valve frame 2000 including an outerframe 2200 and an inner frame 2400 situated at least partially withinouter frame 2200. In some alternative embodiments, the inner frame maybe situated entirely within the outer frame. One or both of the innerframe and the outer frame may be configured to radially expand between aradially-contracted configuration (e.g., a crimped state) and aradially-expanded configuration. In some embodiments, the inner framemay be configured to receive or otherwise support a flow control device,such as one or more leaflets, for regulating flow of blood or otherbodily fluids through the prosthetic valve.

In some embodiments, the plurality of atrial anchoring arms may beconfigured to extend from the inner frame. Additionally, oralternatively, the plurality of ventricular anchoring legs may beconfigured to extend from the annular outer frame. For example, FIG. 3Adepicts atrial anchoring arms 2440 extending from inner frame 2400, andFIG. 3C depicts ventricular anchoring legs 2240 extending from outerframe 2200. In some embodiments, the atrial anchoring arms and theventricular anchoring legs may be physically connected to the innerframe and annular outer frame, respectively, such as by welding oradhesive. In some alternative embodiments, the atrial anchoring arms andthe ventricular anchoring legs may be integrally formed with the innerframe and annular outer frame, respectively.

In some embodiments, at least one of the annular outer frame and theinner frame may be symmetrical about the longitudinal axis of theprosthetic valve. For example, in some embodiments, both the annularouter frame and the inner frame may be symmetrical about thelongitudinal axis of the prosthetic valve.

In some embodiments, the inner frame may be formed at least partially ofa plurality of supporting members or struts. The struts may intersect atjunctions to form a repeating, lattice pattern extending around thecircumference of the inner frame. For example, as illustrated in FIG.3A, inner frame 2400 may be formed of inner frame atrial struts 3008 a,inner frame intermediate struts 3008 b, and inner frame ventricularstruts 3008 c intersecting at atrial end inner frame junctions 3002, armattachment junctions 3202, inner frame junctions 3204, and ventricularend inner frame junctions 3004. The inner frame struts may intersect atthe inner frame junctions to form a repeating pattern of diamond shapedcells 3012 and 3014, as illustrated in FIG. 3A. This strut pattern mayrepeat around the circumference of inner frame 2400; accordingly, innerframe 2400 may be symmetrical about the longitudinal axis of theprosthetic valve.

Similarly, outer frame 2200 illustrated in FIG. 3C may include outerframe atrial circumferential struts 3608 a, outer frame leg base struts3608 b, and outer frame ventricular circumferential struts 3608 cintersecting at atrial end outer frame junctions 3602, leg attachmentjunctions 3802, outer frame junctions 3804, and ventricular end outerframe junctions 3604. The outer frame struts may intersect at the outerframe junctions to form a repeating pattern of chevron shaped cells3616, as illustrated in FIG. 3C. This strut pattern may repeat aroundthe circumference of outer frame 2200; accordingly, outer frame 2200 mayalso be symmetrical about the longitudinal axis of the prosthetic valve.

Because of the symmetry of inner frame 2400 and outer frame 2200, aswell as the symmetry of the atrial anchoring arms 2440 and ventricularanchoring legs 2240 discussed above, the exemplary prosthetic valve 6000may also be symmetrical about longitudinal axis 2800. As a result, theprosthetic valve may be implanted in the native heart valve independentof the rotational position of the prosthetic valve relative to thenative heart valve. As explained above, because the atrial anchoringarms and ventricular anchoring legs are arranged symmetrically about theprosthetic valve, the atrial anchoring arms and ventricular anchoringlegs are configured to anchor the prosthetic valve within the nativevalve at any rotational relationship between the prosthetic valve andthe native valve. In addition, because of the symmetry of the innerframe 2400 and outer frame 2200, the prosthetic valve can also beimplanted at any rotational position of the annular valve body 2020.

The foregoing description has been presented for purposes ofillustration. It is not exhaustive and is not limited to precise formsor embodiments disclosed. Modifications and adaptations of theembodiments will be apparent from consideration of the specification andpractice of the disclosed embodiments. For example, while certaincomponents have been described as being coupled to one another, suchcomponents may be integrated with one another or distributed in anysuitable fashion.

Moreover, while illustrative embodiments have been described herein, thescope includes any and all embodiments having equivalent elements,modifications, omissions, combinations (e.g., of aspects across variousembodiments), adaptations and/or alterations based on the presentdisclosure. The elements in the claims are to be interpreted broadlybased on the language employed in the claims and not limited to examplesdescribed in the present specification or during the prosecution of theapplication, which examples are to be construed as nonexclusive.Further, the steps of the disclosed methods can be modified in anymanner, including reordering steps and/or inserting or deleting steps.

The features and advantages of the disclosure are apparent from thedetailed specification, and thus, it is intended that the appendedclaims cover all systems and methods falling within the true spirit andscope of the disclosure. As used herein, the indefinite articles “a” and“an” mean “one or more.” Similarly, the use of a plural term does notnecessarily denote a plurality unless it is unambiguous in the givencontext. Words such as “and” or “or” mean “and/or” unless specificallydirected otherwise. Further, since numerous modifications and variationswill readily occur from studying the present disclosure, it is notdesired to limit the disclosure to the exact construction and operationillustrated and described, and, accordingly, all suitable modificationsand equivalents may be resorted to, falling within the scope of thedisclosure.

Other embodiments will be apparent from consideration of thespecification and practice of the embodiments disclosed herein. It isintended that the specification and examples be considered as exampleonly, with a true scope and spirit of the disclosed embodiments beingindicated by the following claims.

What is claimed is:
 1. A prosthetic valve for implantation within anative heart valve, the prosthetic valve comprising: an annular valvebody; a plurality of ventricular anchoring legs configured to extendradially outward from the annular valve body to respective terminal legends; and a plurality of atrial anchoring arms configured to extendradially outward from the annular valve body, each atrial anchoring armincluding: a grasping segment situated within a radially inner portionof the atrial anchoring arm, and an anchoring segment situated within aradially outer portion of the atrial anchoring arm, wherein theventricular anchoring legs and the grasping segments of the atrialanchoring arms are configured to substantially restrict axial movementof the annular valve body within the native heart valve, and wherein theanchoring segments of the atrial anchoring arms are configured forlateral deformation relative to the native heart valve.
 2. Theprosthetic valve of claim 1, wherein the ventricular anchoring legs andthe grasping segments of the atrial anchoring arms are configured tograsp heart valve tissue and to substantially restrict axial and lateralmovement of the annular valve body relative to the grasped tissue. 3.The prosthetic valve of claim 1, wherein the ventricular anchoring legsand the grasping segments of the atrial anchoring arms are configured toapply opposing grasping forces upon the native heart valve.
 4. Theprosthetic valve of claim 1, wherein the annular valve body isconfigured to be implanted in the native heart valve independent of therotational position of the atrial anchoring arms and ventricularanchoring legs relative to the native heart valve.
 5. The prostheticvalve of claim 1, wherein the anchoring segments of the atrial anchoringarms are configured for greater flexibility than the ventricularanchoring legs and the grasping segments of the atrial anchoring arms.6. The prosthetic valve of claim 5, wherein flexibility of the anchoringsegments of the atrial anchoring arms is imparted through a structurehaving multiple curves.
 7. The prosthetic valve of claim 6, wherein theventricular anchoring legs and the grasping segments of the atrialanchoring arms are devoid of the structure having multiple curves. 8.The prosthetic valve of claim 1, wherein the flexibility of eachventricular anchoring leg is substantially the same.
 9. The prostheticvalve of claim 1, wherein a portion of at least one atrial anchoring armis configured to be substantially aligned in a common lateral plane witha portion of at least one ventricular anchoring leg.
 10. The prostheticvalve of claim 9, wherein at least the majority of the anchoring segmentof the at least one atrial anchoring arm is configured to be situatedradially external to the portion of the at least one atrial anchoringarm aligned in the common lateral plane.
 11. The prosthetic valve ofclaim 1, wherein the grasping segment of at least one atrial anchoringarm is configured to have a length substantially equal to a length of atleast one ventricular anchoring leg.
 12. The prosthetic valve of claim1, wherein the grasping segment of at least one atrial anchoring armincludes: a first portion configured to extend in an atrial direction,and a second portion configured to extend in a ventricular direction,the second portion of the grasping segment configured to be situatedradially external to the first portion of the grasping segment.
 13. Theprosthetic valve of claim 1, wherein the anchoring segment of at leastone atrial anchoring arm includes: a first portion configured to extendin a ventricular direction, and a second portion configured to extend inan atrial direction, the second portion of the anchoring segmentconfigured to be situated radially external to the first portion of theanchoring segment.
 14. The prosthetic valve of claim 1, wherein anentire length of at least one ventricular anchoring leg is configured toextend in an atrial direction.
 15. The prosthetic valve of claim 1,wherein the ventricular anchoring legs are angularly offset from theatrial anchoring arms, and wherein terminal arm ends of the atrialanchoring arms are configured to be situated radially external to theterminal leg ends.
 16. The prosthetic valve of claim 1, wherein at leastone atrial anchoring arm is configured for radial movement independentof the other atrial anchoring arms; and wherein at least one ventricularanchoring leg is configured for radial movement independent of the otherventricular anchoring legs.
 17. The prosthetic valve of claim 1, whereinthe annular valve body includes an atrial end, a ventricular endopposite the atrial end, and an intermediate portion extending betweenthe atrial end and the ventricular end of the annular valve body; andwherein the atrial anchoring arms and the ventricular anchoring legs areconfigured to extend from the intermediate portion of the annular valvebody.
 18. The prosthetic valve of claim 17, wherein the annular valvebody includes an atrial inlet opening at the atrial end of the annularvalve body, and wherein at least one atrial anchoring arm is configuredto have a length larger than the radius of the atrial inlet opening ofthe annular valve body.
 19. The prosthetic valve of claim 1, wherein theannular valve body comprises: an annular outer frame, the ventricularanchoring legs extending from the outer frame; and an inner framesituated at least partially within the annular outer frame, the atrialanchoring arms extending from the inner frame.
 20. The prosthetic valveof claim 19, wherein at least one of the outer frame and inner frame aresymmetrical.